K965156 is an FDA 510(k) clearance for the ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II — Special Controls, product code KWL).
Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on January 24, 1997, 32 days after receiving the submission on December 23, 1996.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K965156 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1996 |
| Decision Date | January 24, 1997 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWL — Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3360 |