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510(k) K103623

NEWDEAL INTERPHALANGEAL IMPLANT by Newdeal Sas — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2012
Date Received
December 10, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K073375 — NEWDEAL TIBIAXYS SYSTEM (February 21, 2008)
  • K071639 — QWIX POSITIONING SCREW (July 9, 2007)
  • K070447 — NEWDEAL COMPRESSION PLATE (March 29, 2007)
  • K063831 — BASAL DORSAL PLATES (February 7, 2007)

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