The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Periarticular Locking Plate System.
| Device ID | K111039 |
| 510k Number | K111039 |
| Device Name: | ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM |
| Classification | Plate, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-14 |
| Decision Date | 2011-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024092044 | K111039 | 000 |
| 00889024091979 | K111039 | 000 |
| 00889024091887 | K111039 | 000 |
| 00889024091726 | K111039 | 000 |