K130126 is an FDA 510(k) clearance for the SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM. 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 August 6, 2013, 201 days after receiving the submission on January 17, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3670.
| 510(k) Number | K130126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2013 |
| Decision Date | August 06, 2013 |
| Days to Decision | 201 days |
| Submission Type | Traditional |
| 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 |