K100562 is an FDA 510(k) clearance for the LATITUDE ELBOW PROSTHESIS. This device is classified as a Prosthesis, Elbow, Semi-constrained, Cemented (Class II - Special Controls, product code JDB).
Submitted by Tornier, Inc. (Beverly, US). The FDA issued a Cleared decision on June 29, 2010, 120 days after receiving the submission on March 1, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3160.
| 510(k) Number | K100562 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2010 |
| Decision Date | June 29, 2010 |
| Days to Decision | 120 days |
| Submission Type | Special |
| 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 |