Once you have submitted your 510(k), the FDA has 90 days to review it. Please note that review does not mean clearance. During the review process, they likely will ask you for additional information at which time the "clock" is stopped and then resumed upon the FDA's receipt of your answer to their questions. If your product is cleared, the FDA will mail you a letter, with an assigned 510(k) number, that says they "have determined that your device is substantially equivalent to legally marketed predicate devices – and you may therefore begin to market your device subject to the general controls provisions of the Food, Drug and Cosmetics Act."
Essentially, when the FDA sends you this letter, they are not "approving" your device, they are saying that your device is substantially equivalent to the predicate device(s) selected in your 510(k), and which has already been cleared for sale by the FDA, and that you are now cleared to sell your device. You will not receive a certificate from the FDA, but this letter will be available on the FDA database as proof to your customers that your product is cleared for sale in the US.
Once you have received your FDA 510(k) "clearance" letter, the final step is to complete the FDA device listing and establishment registration using the online FURLS system on the FDA website.
B. Sonny Bal, MD, MBA, JD
Greetings! I am an Orthopaedic Surgeon in the Department of Orthopaedic Surgery, at the University of Missouri. I see patients and perform surgery here in Columbia, MO. Over the last 20 years, I have performed thousands of hip and knee replacements, for patients who have visited from around the country, and overseas. My present focus is on patient-specific implant technology, particularly as an innovation to drive consistent outcomes, patient quality, and safety of surgery. Before joining the University in 1999, I was in private practice for 4 years in Blue Springs, MO.
I also have an academic appointment in the Department of Material Sciences, at the Missouri Science & Technology University in Rolla, MO. My research interest is in ceramic biomaterials. I have worked with colleagues in Japan and France to develop the next generation of super-tough silicon nitride ceramic materials for use in skeletal reconstruction. Examples of my research are captured in the publications section of my curriculum vitae, located here.
I am also a lawyer with an interest in medicolegal education. My law colleague, Lawrence Brenner and I have published extensively in this area, and we have presented our work at many conferences. I have provided expert witness services on behalf of hospitals, nursing homes, physicians, orthopaedic manufacturers, and injured patients for many prestigious law firms around the country.
I have helped design orthopaedic implants for several orthopaedic manufacturers, and continue to do so. In this capacity, I also teach other surgeons around the country, specifically, in how to use newly-developed implants, and principles of safe surgery.
I serve as Chief Executive Officer and President of Amedica Corporation, located in Salt Lake City This appointment relates to my interest in silicon nitride ceramics, since Amedica manufactures and sells orthopaedic implants made of medical-grade silicon nitride. My role is to faciliate research and development of the company’s biomaterial and product line, and publish and present the findings in worldwide forums.
Expect to see this at $5+ by April.
Pursuant to Section 510(k), the FDA has 90 days in which to either clear the Class II medical device for commercial distribution or to seek additional information. The FDA previously confirmed that it would review the product as a medical device. Following notification of FDA clearance, the Company would immediately have the right to commence manufacturing, marketing and sales of the product in the United States and its possessions subject to FDA jurisdiction.
think we have another day or two to rally before consolidation in the high $4's or $5's
seriously? They have permission to start phase 1/2 trials mid 2016. It will be years before we get to phase 3 and then another year or two before submission for approval. These news headlines are good for one day pops and should be sold, absent any news of partnerships, etc.
Review of my Wocket Wallet
July 20, 2015 Dustin Wallersmart wallet, Wallaby, wocket wallet
A couple of months ago I wrote about purchasing my Wocket Wallet. Back on June 1st, I received my invitation to purchase my Wocket Wallet and the second I received it, I took out my credit card and purchased it. About a month later I received it. After using it for about 3 weeks, I felt it was time to give a review on it.
The idea of having 1 card that lets me access all my credit cards was extremely appealing. I wouldn’t need to carry 8 or more cards anymore plus it could carry my discount or loyalty cards as well. Over the last few weeks there have been some awesome moments and lets say not so awesome moments with my Wocket.
Once I received my Wocket, I was able to start it right up and load my cards onto the device with absolutely no issue. The touchscreen was very responsive and the wallet wasn’t super thick. I had all my cards loaded onto the Wocket in about 45 minutes.
RIght out of the box, I thought the qualify was outstanding. The Wocket doesn’t feel cheap, it is a very solid device and even the leather card holder is made well. It was very easy to slide out of the wallet holder to add my cards and easy to slide back into place. Initially, it was difficult to remove the card from the wallet, but it has since loosened up and I can now remove the card with one hand.
After loading my cards, I HAD to use it, so I decided to go to the grocery store to pick up a few things. I will admit I was a little nervous about it, but since I had read some issues other people were having, I had a back up credit card just in case. I had no interest in using that card unless it was a last resort. But, as I checked out, there was no issue at all in using my Wocket. SCORE!
In the course of selling Wockets directly to consumers via the their website (wocketwallet.com) and using specialized channels it's become clear that achieving large volumes and scale will come much faster using a B2B approach. Our first example is a new development and distribution agreement with a travel-focused company called WorldVentures.1
This has major advantages for NXTD investors. The company can focus on what they do best which is technology and product development and leverage large value-added industry channels like WorldVentures for customization and distribution.
Nxt-ID Forms New Alliance With WorldVentures 24/7 Wall St. 21 days ago
NXT-ID, INC. Files SEC form 8-K, Entry into a Material Definitive Agreement, Unregistered Sale of Equity Securities, EDGAR Online 21 days ago
The impact on numbers is dramatic - although the company will fall well short of our 40K unit estimate for 2015 they will greatly exceed our current 120K estimate for 2016. If all goes as planned NXT-ID will "pull forward" our volume forecast by about two years. Additional partnerships like the one with WorldVenturs are targeted for other consumer-oriented markets.
The "shift" to EMV or "chip cards" has muddied the waters in the payment space and made it more difficult for early Wocket customers to enjoy a high level of acceptance. Nearly every major retailer has adopted a slightly different method of dealing with the situation - some have turned off EMV, others support both EMV and traditional swipe, others see the mess as a good excuse to go "all the way" with NFC and mobile payments.
For NXT-ID that means rolling out an NFC-based version of the Wocket which will allow consumers to enjoy broad acceptance of their Wocket card and simpler use at the point of sale. The testing and acceptance process with the major issuers takes time so we're not expecting a new version on the market until 1H2016 but we fully expect the card payment space to remain in a state of flux through that time period. Meanwhile NXT-ID will have plenty to focus on in terms of delivering against their new deal with WorldVentures.
Our IV changes are detailed below but our new IV of $6.13 suggests large reward versus the risk reflected in the current share price. If NXT-ID were a private company doing a venture round the valuation would be at least 10x the current share price.
Link to the full report:
The sky is the limit for this company. Wish I had more money to invest.
Jesus Jessi- you and your boiler room are the most annoying bunch to ever muddy up a message board forum. Your 24/7 posts are having the opposite effect. I and my friends tell people that the site contains a virus that will steal their personal information. Let's see who folds first.
not shippers, just the index.
Split must have had something to do with that but that is still a huge increase.
Will they have to reverse split by 1/29 if they don't maintain at least a one dollar closing price? Don't they have to maintain at least $1 for 10 consecutive days? New to this stock. Do they have any more extensions or lifelines to avoid stock split or delisting?
We are going to 1500 on the SPY and 20 for oil and that's conservative. The Dakotas has a gas station selling gas for 47 cents/gallon. Oil can theoretically go to zero based on speculation and futures contracts.
Very low volume. Watch out for the rug getting pulled out from under you after lunch. Great swing trade but would to hold long or short over night.
Train is leaving the station!!!!
Once we break .30 we should have limited over head resistance