K920969 is an FDA 510(k) clearance for the HYDROXYLAPATITE INFINITY(R). This device is classified as a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II - Special Controls, product code MEH).
Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on May 5, 1993, 429 days after receiving the submission on March 2, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353.
| 510(k) Number | K920969 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 1992 |
| Decision Date | May 05, 1993 |
| Days to Decision | 429 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3353 |