K922861 is an FDA 510(k) clearance for the BIOMETRIC SCREW FIXATION CUP. This device is classified as a Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (Class III - Premarket Approval, product code JDL).
Submitted by Osteo Technology, Inc. (Timonium, US). The FDA issued a Cleared decision on May 12, 1993, 342 days after receiving the submission on June 4, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3320.
| 510(k) Number | K922861 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 1992 |
| Decision Date | May 12, 1993 |
| Days to Decision | 342 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | JDL — Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 888.3320 |