Submission Details
| 510(k) Number | K102410 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 24, 2010 |
| Decision Date | December 21, 2010 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
K102410 is an FDA 510(k) clearance for the MATRYX INTERFERENCE SCREW (5.0-6.5MM), a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on December 21, 2010, 119 days after receiving the submission on August 24, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K102410 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 24, 2010 |
| Decision Date | December 21, 2010 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC — Screw, Fixation, Bone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3040 |