Home / 510(k) Clearances / K091609

510(k) K091609

NEWDEAL COMPRESSION PLATE by Newdeal Sas — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2009
Date Received
June 3, 2009
Clearance Type
Special
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)
  • 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)

Other clearances for product code HRS

  • K253906 — Xpert Hand (March 11, 2026)
  • K260069 — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (March 9, 2026)
  • K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (March 3, 2026)
  • 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)
  • K254002 — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13 (January 15, 2026)