Cleared Special

COHESION BONE CEMENT

K103816 · Teknimed Sas · Orthopedic

Feb 2011

Decision

37d

Days

Class 2

Risk

About This 510(k) Submission

K103816 is an FDA 510(k) clearance for the COHESION BONE CEMENT, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by Teknimed Sas (Round Rock, US). The FDA issued a Cleared decision on February 4, 2011, 37 days after receiving the submission on December 29, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K103816 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2010
Decision Date	February 04, 2011
Days to Decision	37 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF