The following data is part of a premarket notification filed by S.b.m Sas Science For Bio Materials with the FDA for Fixit Threaded Anchor System.
| Device ID | K170868 |
| 510k Number | K170868 |
| Device Name: | FIXIT Threaded Anchor System |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | S.B.M SAS Science For Bio Materials ZI Du Monge Lourdes, FR 65100 |
| Contact | Anne Cospin-latapie |
| Correspondent | Anne Cospin-latapie S.B.M SAS Science For Bio Materials ZI Du Monge Lourdes, FR 65100 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-23 |
| Decision Date | 2017-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760154008921 | K170868 | 000 |
| 03760154008273 | K170868 | 000 |
| 03760154008280 | K170868 | 000 |
| 03760154008211 | K170868 | 000 |
| 03760154008228 | K170868 | 000 |
| 03760154008235 | K170868 | 000 |
| 03760154008846 | K170868 | 000 |
| 03760154008860 | K170868 | 000 |
| 03760154008884 | K170868 | 000 |
| 03760154008907 | K170868 | 000 |
| 03760154008914 | K170868 | 000 |
| 03760154008853 | K170868 | 000 |