K950009 is an FDA 510(k) clearance for the POWERGRIP(TM) COMPRESSION FIXATION DEVICE. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).
Submitted by Synvasive Technology, Inc. (Rancho Cordova, US). The FDA issued a Cleared decision on August 18, 1995, 227 days after receiving the submission on January 3, 1995.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K950009 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 1995 |
| Decision Date | August 18, 1995 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | JDW — Pin, Fixation, Threaded |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |