The following data is part of a premarket notification filed by Teknimed Sa with the FDA for Spine-fix Biomimetic Bone Cement.
Device ID | K043593 |
510k Number | K043593 |
Device Name: | SPINE-FIX BIOMIMETIC BONE CEMENT |
Classification | Cement, Bone, Vertebroplasty |
Applicant | TEKNIMED SA 1001 OAKWOOD BLVD Round Rock, TX 78681 |
Contact | J. D. Webb |
Correspondent | J. D. Webb TEKNIMED SA 1001 OAKWOOD BLVD Round Rock, TX 78681 |
Product Code | NDN |
CFR Regulation Number | 888.3027 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-12-29 |
Decision Date | 2006-03-17 |
Summary: | summary |