The following data is part of a premarket notification filed by Medshape Solutions with the FDA for Dynnail, 12mm, Locking Screw, 4.6 Mm, Deployment Frame, Dynnail, Models 1200-01-1222, 1200-02-46xx, 2200-01-0000.
| Device ID | K101934 |
| 510k Number | K101934 |
| Device Name: | DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | MEDSHAPE SOLUTIONS 1575 NORTHSIDE DR. SUITE 440 Atlanta, GA 30318 |
| Contact | Don Griffin |
| Correspondent | Don Griffin MEDSHAPE SOLUTIONS 1575 NORTHSIDE DR. 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 | 2010-07-12 |
| Decision Date | 2011-08-03 |
| Summary: | summary |