K020948 is an FDA 510(k) clearance for the SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II. This device is classified as a Staple, Fixation, Bone (Class II - Special Controls, product code JDR).
Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on October 9, 2002, 198 days after receiving the submission on March 25, 2002.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K020948 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2002 |
| Decision Date | October 09, 2002 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDR — Staple, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |