K043100 is an FDA 510(k) clearance for the BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS. This device is classified as a Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (Class II - Special Controls, product code MBF).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 17, 2005, 100 days after receiving the submission on November 9, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3670.
| 510(k) Number | K043100 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2004 |
| Decision Date | February 17, 2005 |
| Days to Decision | 100 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBF — Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3670 |