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510(k) K101808

SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER by Medshape Solutions — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2010
Date Received
June 29, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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