K131112 is an FDA 510(k) clearance for the LIMACORPORATE SMR CTA HUMERAL HEADS. This device is classified as a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II - Special Controls, product code KWS).
Submitted by Lima Corporate S.P.A. (Winona Lake, US). The FDA issued a Cleared decision on June 7, 2013, 46 days after receiving the submission on April 22, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660.
| 510(k) Number | K131112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2013 |
| Decision Date | June 07, 2013 |
| Days to Decision | 46 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3660 |