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510(k) K063831

BASAL DORSAL PLATES by Newdeal Sas — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2007
Date Received
December 26, 2006
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

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  • K093914 — NEWDEAL COMPRESSION PLATES (April 14, 2011)
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  • 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)

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