The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Zirconia Ceramic Head (yitria Stabilized).
| Device ID | K885069 |
| 510k Number | K885069 |
| Device Name: | ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | F Games |
| Correspondent | F Games RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| 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 | 1988-12-08 |
| Decision Date | 1989-09-01 |