The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Gmk Revision Femoral Distal Augmentation.
| Device ID | K163311 |
| 510k Number | K163311 |
| Device Name: | GMK Revision Femoral Distal Augmentation |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Elizabeth Rose Mapi USA, Inc. 2343 Alexandria Drive Suite 100 Lexington, KY 40504 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-23 |
| Decision Date | 2016-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030888977 | K163311 | 000 |
| 07630030877155 | K163311 | 000 |
| 07630030885129 | K163311 | 000 |
| 07630030885488 | K163311 | 000 |
| 07630030885495 | K163311 | 000 |
| 07630030885501 | K163311 | 000 |
| 07630030888861 | K163311 | 000 |
| 07630030888878 | K163311 | 000 |
| 07630030888885 | K163311 | 000 |
| 07630030888892 | K163311 | 000 |
| 07630030888908 | K163311 | 000 |
| 07630030888915 | K163311 | 000 |
| 07630030888922 | K163311 | 000 |
| 07630030888939 | K163311 | 000 |
| 07630030888946 | K163311 | 000 |
| 07630030888953 | K163311 | 000 |
| 07630030888960 | K163311 | 000 |
| 07630030877131 | K163311 | 000 |