The following data is part of a premarket notification filed by Medshape, Inc with the FDA for Dynanail Ankle Arthrodesis Nail.
| Device ID | K113828 |
| 510k Number | K113828 |
| Device Name: | DYNANAIL ANKLE ARTHRODESIS NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | MEDSHAPE, INC 1575 NORTHSIDE DRIVE, SUITE 440 Atlanta, GA 30318 |
| Contact | Jeremy Blair |
| Correspondent | Jeremy Blair MEDSHAPE, INC 1575 NORTHSIDE DRIVE, SUITE 440 Atlanta, GA 30318 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-27 |
| Decision Date | 2012-02-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M970120001122204 | K113828 | 000 |
| M970120003506500 | K113828 | 000 |
| M970120002506009 | K113828 | 000 |
| M970120002505500 | K113828 | 000 |
| M970120002505008 | K113828 | 000 |
| M970120002504500 | K113828 | 000 |
| M970120002504007 | K113828 | 000 |
| M970120002503500 | K113828 | 000 |
| M970120002503006 | K113828 | 000 |
| M970120002502500 | K113828 | 000 |
| M970120003507000 | K113828 | 000 |
| M970120003507500 | K113828 | 000 |
| M970120003508000 | K113828 | 000 |
| M97012000112220 | K113828 | 000 |
| M970120001102202 | K113828 | 000 |
| M97012000110220 | K113828 | 000 |
| M970120003511006 | K113828 | 000 |
| M970120003510509 | K113828 | 000 |
| M970120003510005 | K113828 | 000 |
| M970120003509500 | K113828 | 000 |
| M970120003509000 | K113828 | 000 |
| M970120003508500 | K113828 | 000 |
| M970120002502005 | K113828 | 000 |