Home / 510(k) Clearances / K070170

510(k) K070170

DALL-MILES SYSTEM by Stryker Orthopaedics — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2007
Date Received
January 18, 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 Stryker Orthopaedics

  • K211703 — Insignia Hip Stem (August 16, 2021)
  • K191414 — EXETER Centralizer, EXETER 2.5mm Plug (August 28, 2019)
  • K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (March 19, 2018)
  • K173849 — Triathlon Total Knee System (February 2, 2018)
  • K172326 — Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (October 30, 2017)
  • K153345 — Stryker Orthopaedics Hip Systems Labeling Update (May 25, 2016)
  • K151264 — Restoration Anatomic Shell (August 10, 2015)
  • K143085 — Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments (February 9, 2015)
  • K143393 — Triathlon Tritanium Cone Augments (January 13, 2015)
  • K142462 — Restoration Anatomic Shell (November 14, 2014)

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)