The following data is part of a premarket notification filed by Sbm Sciences For Bio Materials with the FDA for Ligafix Interference Screw.
| Device ID | K122228 |
| 510k Number | K122228 |
| Device Name: | LIGAFIX INTERFERENCE SCREW |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | SBM SCIENCES FOR BIO MATERIALS ZI DU MONGE Lourdes, FR 65100 |
| Contact | Denis Clement |
| Correspondent | Denis Clement SBM 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 | 2012-07-26 |
| Decision Date | 2012-10-03 |
| Summary: | summary |