510(k) K940744

SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION by Sofamor Co. — Product Code KWQ

K940744 is an FDA 510(k) premarket notification submitted by Sofamor Co. for the device "SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION". The FDA issued a decision of SN on January 30, 1996. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Sofamor Co. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
January 30, 1996
Date Received
February 17, 1994
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