Cleared Traditional

SPINE WORKS COLLAR

K003662 · Spine Works · Neurology

Jul 2001

Decision

223d

Days

Class 2

Risk

About This 510(k) Submission

K003662 is an FDA 510(k) clearance for the SPINE WORKS COLLAR, a Tong, Skull For Traction (Class II — Special Controls, product code HAX), submitted by Spine Works (Traverse City, US). The FDA issued a Cleared decision on July 9, 2001, 223 days after receiving the submission on November 28, 2000. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5960.

Submission Details

510(k) Number	K003662 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 2000
Decision Date	July 09, 2001
Days to Decision	223 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF