The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Periarticular Locking Plates And Screws, Model 2358 Series.
| Device ID | K051098 |
| 510k Number | K051098 |
| Device Name: | PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES |
| Classification | Screw, Fixation, Bone |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Laura D Williams |
| Correspondent | Laura D Williams 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 | 2005-04-29 |
| Decision Date | 2005-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024057005 | K051098 | 000 |
| 00889024056985 | K051098 | 000 |
| 00889024056978 | K051098 | 000 |
| 00889024056992 | K051098 | 000 |
| 00889024089686 | K051098 | 000 |
| 00889024089679 | K051098 | 000 |
| 00889024089662 | K051098 | 000 |
| 00889024089655 | K051098 | 000 |