510(k) K071927

MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT by Depuy Spine, A Johnson & Johnson Company — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2007
Date Received
July 12, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Bone, Vertebroplasty
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type