The following data is part of a premarket notification filed by Influence, Inc. with the FDA for In-fast Bone Screw System/in-fast Bone Screw Inserter/in-fast Bone Screw.
| Device ID | K970292 |
| 510k Number | K970292 |
| Device Name: | IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | INFLUENCE, INC. 601 MONTGOMERY ST., SUITE 845 San Francisco, CA 94111 |
| Contact | Peter Bick |
| Correspondent | Peter Bick INFLUENCE, INC. 601 MONTGOMERY ST., SUITE 845 San Francisco, CA 94111 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-24 |
| Decision Date | 1997-04-23 |
| Summary: | summary |