K033289 is an FDA 510(k) clearance for the MODIFICATION TO JET-X HA COATED HALF PINS. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).
Submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on January 13, 2004, 91 days after receiving the submission on October 14, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K033289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 2003 |
| Decision Date | January 13, 2004 |
| Days to Decision | 91 days |
| Submission Type | Special |
| 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 |