Cleared Special

K150368 - Tarsa-Link Wedge Fixation System
(FDA 510(k) Clearance)

K150368 · Life Spine · Orthopedic

Mar 2015

Decision

40d

Days

Class 2

Risk

K150368 is an FDA 510(k) clearance for the Tarsa-Link Wedge Fixation System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Life Spine (Huntley, US). The FDA issued a Cleared decision on March 24, 2015, 40 days after receiving the submission on February 12, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K150368 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 2015
Decision Date	March 24, 2015
Days to Decision	40 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF