K030710 is an FDA 510(k) clearance for the BIO-MODULAR SHOULDER SYSTEM. This device is classified as a Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (Class II - Special Controls, product code KWT).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 4, 2003, 90 days after receiving the submission on March 6, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3650.
| 510(k) Number | K030710 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2003 |
| Decision Date | June 04, 2003 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWT — Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3650 |