The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Plates And Screws System Screws Only.
| Device ID | K112885 |
| 510k Number | K112885 |
| Device Name: | ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY |
| Classification | Screw, Fixation, Bone |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Stephen H Mckelvey |
| Correspondent | Stephen H Mckelvey ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2011-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024101661 | K112885 | 000 |
| 00889024101647 | K112885 | 000 |
| 00889024101623 | K112885 | 000 |
| 00889024101609 | K112885 | 000 |
| 00889024101586 | K112885 | 000 |
| 00889024101562 | K112885 | 000 |
| 00889024101548 | K112885 | 000 |
| 00889024101524 | K112885 | 000 |