K083654 is an FDA 510(k) clearance for the ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM). This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 26, 2009, 78 days after receiving the submission on December 10, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K083654 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2008 |
| Decision Date | February 26, 2009 |
| Days to Decision | 78 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |