K994143 is an FDA 510(k) clearance for the SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).
Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on February 18, 2000, 72 days after receiving the submission on December 8, 1999.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K994143 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 1999 |
| Decision Date | February 18, 2000 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDW — Pin, Fixation, Threaded |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |