Cleared Traditional

HIGH V+

K161114 · Teknimed Sas · Orthopedic

Apr 2017

Decision

357d

Days

Class 2

Risk

About This 510(k) Submission

K161114 is an FDA 510(k) clearance for the HIGH V+, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by Teknimed Sas (L'Union, FR). The FDA issued a Cleared decision on April 12, 2017, 357 days after receiving the submission on April 20, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K161114 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 20, 2016
Decision Date	April 12, 2017
Days to Decision	357 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF