The following data is part of a premarket notification filed by Synvasive Technology, Inc. with the FDA for Powergrip(tm) Compression Fixation Device.
| Device ID | K950009 |
| 510k Number | K950009 |
| Device Name: | POWERGRIP(TM) COMPRESSION FIXATION DEVICE |
| Classification | Pin, Fixation, Threaded |
| Applicant | SYNVASIVE TECHNOLOGY, INC. 11328 SUNRISE GOLD CIRCLE Rancho Cordova, CA 95742 |
| Contact | Gary A Seeger |
| Correspondent | Gary A Seeger SYNVASIVE TECHNOLOGY, INC. 11328 SUNRISE GOLD CIRCLE Rancho Cordova, CA 95742 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-03 |
| Decision Date | 1995-08-18 |