The following data is part of a premarket notification filed by S.b.m. Sas Sciences For Bio Materials with the FDA for Fixit / Compositcp Threaded Anchor System.
| Device ID | K180960 |
| 510k Number | K180960 |
| Device Name: | FIXIT / ComposiTCP Threaded Anchor System |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | S.B.M. SAS Sciences For Bio Materials ZI Du Monge Lourdes, FR 65100 |
| Contact | Anne Cospin-latapie |
| Correspondent | Anne Cospin-latapie S.B.M. SAS Sciences For Bio Materials ZI Du Monge Lourdes, FR 65100 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-12 |
| Decision Date | 2018-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760154007245 | K180960 | 000 |
| 03760154007238 | K180960 | 000 |
| 03760154007221 | K180960 | 000 |
| 03760154008266 | K180960 | 000 |
| 03760154008259 | K180960 | 000 |
| 03760154008242 | K180960 | 000 |
| 03760304681004 | K180960 | 000 |
| 03760304680991 | K180960 | 000 |
| 03760304680984 | K180960 | 000 |