K943548 is an FDA 510(k) clearance for the BIOABSORBABLE INTERFERENCE SCREW. This device is classified as a Staple, Fixation, Bone (Class II - Special Controls, product code JDR).
Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on March 20, 1995, 242 days after receiving the submission on July 21, 1994.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K943548 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 1994 |
| Decision Date | March 20, 1995 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | JDR — Staple, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |