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510(k) K012273

SPIRAL RADIUS 90-D SST SYSTEM by United States Surgical, A Division of Tyco Healthc — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2001
Date Received
July 19, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

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