K943855 is an FDA 510(k) clearance for the BONE FIXATION NAIL. This device is classified as a Nail, Fixation, Bone (Class II - Special Controls, product code JDS).
Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on July 12, 1995, 338 days after receiving the submission on August 8, 1994.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K943855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 1994 |
| Decision Date | July 12, 1995 |
| Days to Decision | 338 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | JDS — Nail, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |