K020097 is an FDA 510(k) clearance for the STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).
Submitted by Stryker Endoscopy (Santa Clara, US). The FDA issued a Cleared decision on March 15, 2002, 64 days after receiving the submission on January 10, 2002.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K020097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 2002 |
| Decision Date | March 15, 2002 |
| Days to Decision | 64 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 |