The following data is part of a premarket notification filed by Depuy Spine, A Johnson & Johnson Company with the FDA for Modification To Vertebroplastic Radiopaque Bone Cement.
Device ID | K071927 |
510k Number | K071927 |
Device Name: | MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT |
Classification | Cement, Bone, Vertebroplasty |
Applicant | DEPUY SPINE, A JOHNSON & JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
Contact | Sharon Starowicz |
Correspondent | Sharon Starowicz DEPUY SPINE, A JOHNSON & JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
Product Code | NDN |
CFR Regulation Number | 888.3027 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-12 |
Decision Date | 2007-11-21 |
Summary: | summary |