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510(k) K080358

PLLA, HA SCREW by Smith & Nephew Inc., Endoscopy Div. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2008
Date Received
February 11, 2008
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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