The following data is part of a premarket notification filed by Linvatec Biomaterials, Ltd. with the FDA for Biosorb Fx And Biosorb Pdx 1.5 And 2.0 Screws.
| Device ID | K042517 |
| 510k Number | K042517 |
| Device Name: | BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS |
| Classification | Plate, Bone |
| Applicant | LINVATEC BIOMATERIALS, LTD. HERMIANKATU 6-8L Tampere, FI |
| Contact | Tuija Annala |
| Correspondent | Tuija Annala LINVATEC BIOMATERIALS, LTD. HERMIANKATU 6-8L Tampere, FI |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-15 |
| Decision Date | 2004-10-08 |
| Summary: | summary |