The following data is part of a premarket notification filed by Science For Biomaterials with the FDA for Ligafix Interface Screw.
| Device ID | K090994 |
| 510k Number | K090994 |
| Device Name: | LIGAFIX INTERFACE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | SCIENCE FOR BIOMATERIALS ZI DU MONGE Lourdes, FR 65100 |
| Contact | Denis Clement |
| Correspondent | Denis Clement SCIENCE FOR BIOMATERIALS ZI DU MONGE Lourdes, FR 65100 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-07 |
| Decision Date | 2009-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760154006934 | K090994 | 000 |
| 03760154006910 | K090994 | 000 |