The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Reconstruction System Symphyseal Bone Plate.
| Device ID | K953714 |
| 510k Number | K953714 |
| Device Name: | ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Lynette Whitaker |
| Correspondent | Lynette Whitaker ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-09 |
| Decision Date | 1995-11-20 |