The following data is part of a premarket notification filed by Conmed Linvatec Biomaterials with the FDA for Matryx Interference Screw, 239038t5,231025t5,231033t5,231038t5,231125t5,231133t5,231138t5.
| Device ID | K063588 |
| 510k Number | K063588 |
| Device Name: | MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 |
| Classification | Screw, Fixation, Bone |
| Applicant | CONMED LINVATEC BIOMATERIALS P.O. BOX 3 HERMIANKATU 6-8L Tampere, FI Fin-33720 |
| Contact | Paivi Mesiranta |
| Correspondent | Paivi Mesiranta CONMED LINVATEC BIOMATERIALS P.O. BOX 3 HERMIANKATU 6-8L Tampere, FI Fin-33720 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-30 |
| Decision Date | 2007-03-02 |
| Summary: | summary |