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510(k) K083154

NEWDEAL HALLU LOCK PLATE SYSTEM by Newdeal Sas — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2009
Date Received
October 24, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Newdeal Sas

  • K103623 — NEWDEAL INTERPHALANGEAL IMPLANT (March 20, 2012)
  • K093914 — NEWDEAL COMPRESSION PLATES (April 14, 2011)
  • K093781 — MODIFIED: NEWDEAL HALLU PLATES (January 22, 2010)
  • K091788 — PANTA NAIL (DIA. 10MM), PANTA NAIL XL (July 29, 2009)
  • K091609 — NEWDEAL COMPRESSION PLATE (June 30, 2009)
  • 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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