The following data is part of a premarket notification filed by Linvatec Biomaterials, Inc. with the FDA for Matryx Interference Screw.
| Device ID | K052080 |
| 510k Number | K052080 |
| Device Name: | MATRYX INTERFERENCE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | LINVATEC BIOMATERIALS, INC. P.O. BOX 3 HERMIANKATU 6-8L Tampere, FI Fin-33720 |
| Contact | Tuija Annala |
| Correspondent | Tuija Annala LINVATEC BIOMATERIALS, INC. P.O. BOX 3 HERMIANKATU 6-8L Tampere, FI Fin-33720 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-02 |
| Decision Date | 2005-08-25 |
| Summary: | summary |