K926156 is an FDA 510(k) clearance for the REPLICA(TM) TOTAL HIP SYSTEM. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II - Special Controls, product code LPH).
Submitted by Osteo Technology, Inc. (Timonium, US). The FDA issued a Cleared decision on March 9, 1994, 457 days after receiving the submission on December 7, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3358.
| 510(k) Number | K926156 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | December 07, 1992 |
| Decision Date | March 09, 1994 |
| Days to Decision | 457 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3358 |