The following data is part of a premarket notification filed by Influence, Inc. with the FDA for Short Straight-in Bone Screw Fixation System.
| Device ID | K982155 |
| 510k Number | K982155 |
| Device Name: | SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | INFLUENCE, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan 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 | 1998-06-18 |
| Decision Date | 1998-08-31 |
| Summary: | summary |