510(k) K853033

HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM by A.W. Showell (Surgicraft) , Ltd. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1985
Date Received
July 18, 1985
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