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510(k) K971289

SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) by Osteotech, Inc. — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1997
Date Received
April 7, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

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