The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Kinamed Cemented Cth Stem.
| Device ID | K902074 |
| 510k Number | K902074 |
| Device Name: | KINAMED CEMENTED CTH STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | KINAMED, INC. 2192-C ANCHOR COURT Newbury Park, CA 91320 |
| Contact | Clarke, Ph.d. |
| Correspondent | Clarke, Ph.d. KINAMED, INC. 2192-C ANCHOR COURT Newbury Park, CA 91320 |
| 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 | 1990-05-07 |
| Decision Date | 1990-06-08 |