510(k) K934429

ANTERIOR SPINE SYSTEM by Buckman Co., Inc. — Product Code KWQ

K934429 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "ANTERIOR SPINE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 20, 1994. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1994
Date Received
September 13, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type