The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Ceramic Total Hip Ball Head, Small Taper.
| Device ID | K891083 |
| 510k Number | K891083 |
| Device Name: | CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Barry R Sisson |
| Correspondent | Barry R Sisson DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-01 |
| Decision Date | 1989-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295034353 | K891083 | 000 |
| 10603295034346 | K891083 | 000 |
| 10603295034339 | K891083 | 000 |
| 10603295034322 | K891083 | 000 |
| 10603295034315 | K891083 | 000 |