K960363 is an FDA 510(k) clearance for the BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143. This device is classified as a Prosthesis, Shoulder, Humeral (bipolar Hemi-shoulder) Metal/polymer, Cemented Or Uncemented (Class III - Premarket Approval, product code MJT).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 18, 1997, 390 days after receiving the submission on January 25, 1996.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K960363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 1996 |
| Decision Date | February 18, 1997 |
| Days to Decision | 390 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MJT — Prosthesis, Shoulder, Humeral (bipolar Hemi-shoulder) Metal/polymer, Cemented Or Uncemented |
| Device Class | Class III - Premarket Approval |