510(k) K003709

SURGICAL DYNAMICS MESH CAGE SYSTEM by United States Surgical, A Division of Tyco Healthc — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2001
Date Received
December 1, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type