The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Periarticular Locking Plates, 2358 Series.
| Device ID | K043227 |
| 510k Number | K043227 |
| Device Name: | PERIARTICULAR LOCKING PLATES, 2358 SERIES |
| Classification | Plate, Fixation, Bone |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Noah Bartsch |
| Correspondent | Noah Bartsch ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-22 |
| Decision Date | 2004-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024056121 | K043227 | 000 |
| 00889024088818 | K043227 | 000 |
| 00889024088801 | K043227 | 000 |
| 00889024088795 | K043227 | 000 |
| 00889024088788 | K043227 | 000 |
| 00889024088771 | K043227 | 000 |
| 00889024088764 | K043227 | 000 |
| 00889024088757 | K043227 | 000 |
| 00889024088740 | K043227 | 000 |
| 00889024088825 | K043227 | 000 |
| 00889024056039 | K043227 | 000 |
| 00889024056077 | K043227 | 000 |
| 00889024056053 | K043227 | 000 |
| 00889024056114 | K043227 | 000 |
| 00889024056107 | K043227 | 000 |
| 00889024056091 | K043227 | 000 |
| 00889024056084 | K043227 | 000 |
| 00889024056060 | K043227 | 000 |
| 00889024056046 | K043227 | 000 |
| 00889024088733 | K043227 | 000 |