Cleared Traditional

K960451 - WEBB-MORLEY SPINE SYSTEM
(FDA 510(k) Clearance)

K960451 · Buckman Co., Inc. · Orthopedic

Apr 1996

Decision

79d

Days

Class 2

Risk

K960451 is an FDA 510(k) clearance for the WEBB-MORLEY SPINE SYSTEM, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on April 18, 1996, 79 days after receiving the submission on January 30, 1996. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K960451 FDA.gov
FDA Decision	Cleared SN
Date Received	January 30, 1996
Decision Date	April 18, 1996
Days to Decision	79 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—