The following data is part of a premarket notification filed by Linvatec Biomaterials, Ltd. with the FDA for Cannulated Nugen Fx Screw Fully Threaded, Cannulated Nugen Fx Screw Partially Threaded.
| Device ID | K032447 |
| 510k Number | K032447 |
| Device Name: | CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED |
| Classification | Screw, Fixation, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-08 |
| Decision Date | 2004-04-16 |
| Summary: | summary |