The following data is part of a premarket notification filed by Linvatec Biomaterials, Inc. with the FDA for Osteo Acl Screw Model;237020t, 237025t, 237030t, 238020t, 238025t, 238030t, 239020t, 239025t, 239030t, 231020t, 231025t,.
| Device ID | K032894 |
| 510k Number | K032894 |
| Device Name: | OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-17 |
| Decision Date | 2004-05-07 |
| Summary: | summary |