K083144 is an FDA 510(k) clearance for the ACUMED CLAVICLE SCREW SYSTEM. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).
Submitted by Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on June 16, 2009, 236 days after receiving the submission on October 23, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K083144 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 2008 |
| Decision Date | June 16, 2009 |
| Days to Decision | 236 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDW — Pin, Fixation, Threaded |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |