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510(k) K071639

QWIX POSITIONING SCREW by Newdeal Sas — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2007
Date Received
June 15, 2007
Clearance Type
Special
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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