K981529 is an FDA 510(k) clearance for the TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW. This device is classified as a Nail, Fixation, Bone (Class II - Special Controls, product code JDS).
Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on July 9, 1998, 71 days after receiving the submission on April 29, 1998.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K981529 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1998 |
| Decision Date | July 09, 1998 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDS — Nail, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |