The following data is part of a premarket notification filed by Influence, Inc. with the FDA for Repose Bone Screw System.
| Device ID | K981677 |
| 510k Number | K981677 |
| Device Name: | REPOSE BONE SCREW SYSTEM |
| Classification | Device, Anti-snoring |
| Applicant | INFLUENCE, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan, Esq. |
| Correspondent | Jonathan S Kahan, Esq. INFLUENCE, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-12 |
| Decision Date | 1999-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169107779 | K981677 | 000 |
| 00643169062979 | K981677 | 000 |