K100123 is an FDA 510(k) clearance for the ACUMED WRIST ARTHRODESIS PLATE SYSTEM. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on October 6, 2010, 264 days after receiving the submission on January 15, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K100123 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 15, 2010 |
| Decision Date | October 06, 2010 |
| Days to Decision | 264 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 |