K994202 is an FDA 510(k) clearance for the ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Smith & Nephew, Inc. (Mansfield, US). The FDA issued a Cleared decision on February 25, 2000, 74 days after receiving the submission on December 13, 1999.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K994202 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 1999 |
| Decision Date | February 25, 2000 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC — Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |