The following data is part of a premarket notification filed by Influence, Inc. with the FDA for Straight-in-orthopedic Bone Screw Fixation System.
| Device ID | K990095 |
| 510k Number | K990095 |
| Device Name: | STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | INFLUENCE, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Peter Bick |
| Correspondent | Peter Bick INFLUENCE, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-12 |
| Decision Date | 1999-02-01 |
| Summary: | summary |