K946346 is an FDA 510(k) clearance for the ACUFEX TAG(R) BIOABSORBABLE ANCHORS. 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 April 26, 1995, 117 days after receiving the submission on December 30, 1994.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K946346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1994 |
| Decision Date | April 26, 1995 |
| Days to Decision | 117 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 |