The following data is part of a premarket notification filed by Medacta International with the FDA for Gmk Extension.
| Device ID | K142069 |
| 510k Number | K142069 |
| Device Name: | GMK EXTENSION |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MEDACTA INTERNATIONAL 1556 W. CARROLL AVENUE Chicago, IL 60607 |
| Contact | Adam Gross |
| Correspondent | Adam Gross MEDACTA INTERNATIONAL 1556 W. CARROLL AVENUE Chicago, IL 60607 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-30 |
| Decision Date | 2014-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030821059 | K142069 | 000 |
| 07630030820144 | K142069 | 000 |
| 07630030820298 | K142069 | 000 |
| 07630030820304 | K142069 | 000 |
| 07630030820410 | K142069 | 000 |
| 07630030820427 | K142069 | 000 |
| 07630030820762 | K142069 | 000 |
| 07630030820779 | K142069 | 000 |
| 07630030820922 | K142069 | 000 |
| 07630030820939 | K142069 | 000 |
| 07630030821042 | K142069 | 000 |
| 07630030820137 | K142069 | 000 |