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510(k) K093914

NEWDEAL COMPRESSION PLATES by Newdeal Sas — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2011
Date Received
December 22, 2009
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)
  • K093781 — MODIFIED: NEWDEAL HALLU PLATES (January 22, 2010)
  • K091788 — PANTA NAIL (DIA. 10MM), PANTA NAIL XL (July 29, 2009)
  • K083154 — NEWDEAL HALLU LOCK PLATE SYSTEM (July 10, 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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