The following data is part of a premarket notification filed by Science For Biomaterials with the FDA for Modification To: Ligafix Interference Screw.
| Device ID | K070507 |
| 510k Number | K070507 |
| Device Name: | MODIFICATION TO: LIGAFIX INTERFERENCE 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 | 2007-02-21 |
| Decision Date | 2007-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760154006859 | K070507 | 000 |
| 03760154006682 | K070507 | 000 |
| 03760154006675 | K070507 | 000 |
| 03760154006668 | K070507 | 000 |
| 03760154006651 | K070507 | 000 |
| 03760154006644 | K070507 | 000 |
| 03760154006637 | K070507 | 000 |
| 03760154006620 | K070507 | 000 |
| 03760154006613 | K070507 | 000 |
| 03760154006699 | K070507 | 000 |
| 03760154006705 | K070507 | 000 |
| 03760154006842 | K070507 | 000 |
| 03760154006774 | K070507 | 000 |
| 03760154006767 | K070507 | 000 |
| 03760154006750 | K070507 | 000 |
| 03760154006743 | K070507 | 000 |
| 03760154006736 | K070507 | 000 |
| 03760154006729 | K070507 | 000 |
| 03760154006712 | K070507 | 000 |
| 03760154006606 | K070507 | 000 |