The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Alumina Ceramic Femoral Heads, 28 And 32 Mm.
| Device ID | K030724 |
| 510k Number | K030724 |
| Device Name: | ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM |
| 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 | Karen Cain |
| Correspondent | Karen Cain 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 | 2003-03-07 |
| Decision Date | 2003-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024126763 | K030724 | 000 |
| 00889024126756 | K030724 | 000 |
| 00889024126749 | K030724 | 000 |
| 00889024126732 | K030724 | 000 |
| 00889024126725 | K030724 | 000 |
| 00889024126718 | K030724 | 000 |