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510(k) K073375

NEWDEAL TIBIAXYS SYSTEM by Newdeal Sas — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2008
Date Received
December 3, 2007
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)
  • K083154 — NEWDEAL HALLU LOCK PLATE SYSTEM (July 10, 2009)
  • K091609 — NEWDEAL COMPRESSION PLATE (June 30, 2009)
  • 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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  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
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