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 |