The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer(r) Ceramic Femoral Heads 28mm Diameter.
| Device ID | K914676 |
| 510k Number | K914676 |
| Device Name: | ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Angie Ide |
| Correspondent | Angie Ide ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-18 |
| Decision Date | 1992-01-13 |