SMARTSCREW
Screw, Fixation, Bone
BIONX IMPLANTS, LTD.
The following data is part of a premarket notification filed by Bionx Implants, Ltd. with the FDA for Smartscrew.
Pre-market Notification Details
| Device ID | K012001 |
| 510k Number | K012001 |
| Device Name: | SMARTSCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | BIONX IMPLANTS, LTD. P.O. BOX 3 HERMINKATU 6-8L Tampere, FI Sp-33721 |
| Contact | Tuija Annala |
| Correspondent | Tuija Annala BIONX IMPLANTS, LTD. P.O. BOX 3 HERMINKATU 6-8L Tampere, FI Sp-33721 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-27 |
| Decision Date | 2001-07-18 |
| Summary: | summary |
Trademark Results [SMARTSCREW]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMARTSCREW 75617175 2523066 Live/Registered |
Linvatec Biomaterials, Inc. 1999-01-07 |
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