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 |