Cleared Traditional

FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM

K980689 · Friddle'S Orthopedic Appliances, Inc. · Neurology

Feb 1999

Decision

360d

Days

Class 2

Risk

About This 510(k) Submission

K980689 is an FDA 510(k) clearance for the FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM, a Tong, Skull For Traction (Class II — Special Controls, product code HAX), submitted by Friddle'S Orthopedic Appliances, Inc. (Honea Path, US). The FDA issued a Cleared decision on February 18, 1999, 360 days after receiving the submission on February 23, 1998. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5960.

Submission Details

510(k) Number	K980689 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 23, 1998
Decision Date	February 18, 1999
Days to Decision	360 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF