The following data is part of a premarket notification filed by Ldr Spine Usa with the FDA for Bf+ (ph).
Device ID | K061462 |
510k Number | K061462 |
Device Name: | BF+ (PH) |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin, TX 78759 |
Contact | Edward E Newton |
Correspondent | Edward E Newton LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin, TX 78759 |
Product Code | MQV |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-05-26 |
Decision Date | 2006-12-15 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BF+ (PH) 78739474 3379420 Dead/Cancelled |
LDR MEDICAL, S.A.S. 2005-10-24 |