K961260 is an FDA 510(k) clearance for the KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY. This device is classified as a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II - Special Controls, product code HSD).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 2, 1997, 365 days after receiving the submission on April 2, 1996.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3690.
| 510(k) Number | K961260 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 1996 |
| Decision Date | April 02, 1997 |
| Days to Decision | 365 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 |