K092419 is an FDA 510(k) clearance for the AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on September 1, 2009, 26 days after receiving the submission on August 6, 2009.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K092419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2009 |
| Decision Date | September 01, 2009 |
| Days to Decision | 26 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 |