K943908 is an FDA 510(k) clearance for the INFINITY SHOULDER SYSTEM. This device is classified as a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II - Special Controls, product code HSD).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on May 30, 1995, 292 days after receiving the submission on August 11, 1994.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3690.
| 510(k) Number | K943908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1994 |
| Decision Date | May 30, 1995 |
| Days to Decision | 292 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3690 |