The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Gmk Revision Knee Sc Liners.
| Device ID | K103170 |
| 510k Number | K103170 |
| Device Name: | GMK REVISION KNEE SC LINERS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego, CA 92129 |
| Contact | Natalie J Kennel |
| Correspondent | Natalie J Kennel MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego, CA 92129 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-27 |
| Decision Date | 2011-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030815911 | K103170 | 000 |
| 07630030816970 | K103170 | 000 |
| 07630030816987 | K103170 | 000 |
| 07630030817076 | K103170 | 000 |
| 07630030817175 | K103170 | 000 |
| 07630030817298 | K103170 | 000 |
| 07630030817410 | K103170 | 000 |
| 07630030817519 | K103170 | 000 |
| 07630030817557 | K103170 | 000 |
| 07630030816932 | K103170 | 000 |
| 07630030816833 | K103170 | 000 |
| 07630030816710 | K103170 | 000 |
| 07630030816017 | K103170 | 000 |
| 07630030816130 | K103170 | 000 |
| 07630030816253 | K103170 | 000 |
| 07630030816352 | K103170 | 000 |
| 07630030816390 | K103170 | 000 |
| 07630030816406 | K103170 | 000 |
| 07630030816499 | K103170 | 000 |
| 07630030816598 | K103170 | 000 |
| 07630030817564 | K103170 | 000 |
| 07630030817656 | K103170 | 000 |
| 07630030818714 | K103170 | 000 |
| 07630030818721 | K103170 | 000 |
| 07630030818813 | K103170 | 000 |
| 07630030818912 | K103170 | 000 |
| 07630030819032 | K103170 | 000 |
| 07630030819155 | K103170 | 000 |
| 07630030819254 | K103170 | 000 |
| 07630030819292 | K103170 | 000 |
| 07630030818677 | K103170 | 000 |
| 07630030818578 | K103170 | 000 |
| 07630030818455 | K103170 | 000 |
| 07630030817755 | K103170 | 000 |
| 07630030817878 | K103170 | 000 |
| 07630030817991 | K103170 | 000 |
| 07630030818097 | K103170 | 000 |
| 07630030818134 | K103170 | 000 |
| 07630030818141 | K103170 | 000 |
| 07630030818233 | K103170 | 000 |
| 07630030818332 | K103170 | 000 |
| 07630030819308 | K103170 | 000 |