The following data is part of a premarket notification filed by Medacta International with the FDA for Gmk Narrow.
| Device ID | K122232 |
| 510k Number | K122232 |
| Device Name: | GMK NARROW |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
| Contact | Adam Gross |
| Correspondent | Adam Gross MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-26 |
| Decision Date | 2012-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030821035 | K122232 | 000 |
| 07630030820397 | K122232 | 000 |
| 07630030820380 | K122232 | 000 |
| 07630030820373 | K122232 | 000 |
| 07630030820366 | K122232 | 000 |
| 07630030820359 | K122232 | 000 |
| 07630030820342 | K122232 | 000 |
| 07630030820335 | K122232 | 000 |
| 07630030820328 | K122232 | 000 |
| 07630030820403 | K122232 | 000 |
| 07630030820946 | K122232 | 000 |
| 07630030821028 | K122232 | 000 |
| 07630030821011 | K122232 | 000 |
| 07630030821004 | K122232 | 000 |
| 07630030820991 | K122232 | 000 |
| 07630030820984 | K122232 | 000 |
| 07630030820977 | K122232 | 000 |
| 07630030820960 | K122232 | 000 |
| 07630030820953 | K122232 | 000 |
| 07630030820311 | K122232 | 000 |