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510(k) K021009

OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM by Spinal Concepts, Inc. — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2002
Date Received
March 28, 2002
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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  • K031837 — MODIFICATION TO FORTITUDE CEMENT RESTRICTOR (July 24, 2003)

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