The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Anatomical Shoulder Fracture System.
| Device ID | K062029 |
| 510k Number | K062029 |
| Device Name: | ANATOMICAL SHOULDER FRACTURE SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Mason W Robbins |
| Correspondent | Mason W Robbins ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-18 |
| Decision Date | 2006-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024286306 | K062029 | 000 |
| 00889024285620 | K062029 | 000 |
| 00889024285637 | K062029 | 000 |
| 00889024285644 | K062029 | 000 |
| 00889024285651 | K062029 | 000 |
| 00889024285668 | K062029 | 000 |
| 00889024285675 | K062029 | 000 |
| 00889024285682 | K062029 | 000 |
| 00889024285934 | K062029 | 000 |
| 00889024285941 | K062029 | 000 |
| 00889024285958 | K062029 | 000 |
| 00889024285965 | K062029 | 000 |
| 00889024286252 | K062029 | 000 |
| 00889024286269 | K062029 | 000 |
| 00889024286276 | K062029 | 000 |
| 00889024286283 | K062029 | 000 |
| 00889024286290 | K062029 | 000 |
| 00889024285613 | K062029 | 000 |