K181362 is an FDA 510(k) clearance for the TEMA Elbow System. This device is classified as a Prosthesis, Elbow, Constrained, Cemented (Class II - Special Controls, product code JDC).
Submitted by Lima Corporate S.P.A. (Villanova Di San Daniele Del Friuli, IT). The FDA issued a Cleared decision on February 16, 2019, 269 days after receiving the submission on May 23, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3150.
| 510(k) Number | K181362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2018 |
| Decision Date | February 16, 2019 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDC — Prosthesis, Elbow, Constrained, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3150 |