The following data is part of a premarket notification filed by Influence, Inc. with the FDA for Straight-in Bone Screw Fixation System.
| Device ID | K972622 |
| 510k Number | K972622 |
| Device Name: | STRAIGHT-IN BONE SCREW FIXATION SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | INFLUENCE, INC. 12037 WINESAP TERRACE North Potomac, MD 20878 -2331 |
| Contact | Mark D Kramer |
| Correspondent | Mark D Kramer INFLUENCE, INC. 12037 WINESAP TERRACE North Potomac, MD 20878 -2331 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-14 |
| Decision Date | 1997-10-09 |
| Summary: | summary |