K061211 is an FDA 510(k) clearance for the NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Zimmer GmbH (Warsaw, US). The FDA issued a Cleared decision on June 14, 2006, 44 days after receiving the submission on May 1, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K061211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2006 |
| Decision Date | June 14, 2006 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| 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 |