K222807 is an FDA 510(k) clearance for the TEMA Elbow system - Line extension. This device is classified as a Prosthesis, Elbow, Semi-constrained, Cemented (Class II - Special Controls, product code JDB).
Submitted by Lima Corporate S.P.A. (Villanova Di San Daniele Del Friuli, IT). The FDA issued a Cleared decision on October 26, 2022, 40 days after receiving the submission on September 16, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3160.
| 510(k) Number | K222807 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2022 |
| Decision Date | October 26, 2022 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDB — Prosthesis, Elbow, Semi-constrained, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3160 |