Cleared Special

MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT

K071927 · Depuy Spine, A Johnson & Johnson Company · Orthopedic

Nov 2007

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K071927 is an FDA 510(k) clearance for the MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by Depuy Spine, A Johnson & Johnson Company (Raynham, US). The FDA issued a Cleared decision on November 21, 2007, 132 days after receiving the submission on July 12, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K071927 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2007
Decision Date	November 21, 2007
Days to Decision	132 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF