The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Matryx Interference Screw (5.0-6.5mm).
Device ID | K102410 |
510k Number | K102410 |
Device Name: | MATRYX INTERFERENCE SCREW (5.0-6.5MM) |
Classification | Screw, Fixation, Bone |
Applicant | CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
Contact | Ashlea Bowen |
Correspondent | Ashlea Bowen CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-24 |
Decision Date | 2010-12-21 |
Summary: | summary |