The following data is part of a premarket notification filed by Sciences For Bio Materials with the FDA for Ligafix Resorbable Interference Screw, Models 30 And 60.
| Device ID | K050407 |
| 510k Number | K050407 |
| Device Name: | LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60 |
| Classification | Screw, Fixation, Bone |
| Applicant | SCIENCES FOR BIO MATERIALS ZI DU MONGE Lourdes, FR F65100 |
| Contact | Denis Clement |
| Correspondent | Denis Clement SCIENCES FOR BIO MATERIALS ZI DU MONGE Lourdes, FR F65100 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-17 |
| Decision Date | 2005-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760154006880 | K050407 | 000 |
| 03760154006866 | K050407 | 000 |
| 03760154006835 | K050407 | 000 |
| 03760154006828 | K050407 | 000 |
| 03760154006811 | K050407 | 000 |