The following data is part of a premarket notification filed by Musculoskeletal Transplant Foundation with the FDA for Dbx Strip.
Device ID | K062205 |
510k Number | K062205 |
Device Name: | DBX STRIP |
Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
Applicant | MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY STREET Edison, NJ 08837 |
Contact | Nancy Bennewitz |
Correspondent | Nancy Bennewitz MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY STREET Edison, NJ 08837 |
Product Code | MBP |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-01 |
Decision Date | 2007-02-05 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DBX STRIP 76515206 3130246 Live/Registered |
MUSCULOSKELETAL TRANSPLANT FOUNDATION 2003-05-16 |