Home / 510(k) Clearances / K221088

510(k) K221088

Anatomic Bone Plate by Double Medical Technology, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2023
Date Received
April 13, 2022
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 Double Medical Technology, Inc.

  • K252729 — Universal Spinal System (November 18, 2025)
  • K242348 — Locking Screw,CoCrMo (December 4, 2024)
  • K233078 — Posterior Cervical Spine System (November 22, 2023)
  • K223753 — Cervical Plate System (March 14, 2023)
  • K221150 — Advanced Bone Plate (January 25, 2023)
  • K221090 — Metal Cannulated Screw (January 10, 2023)
  • K221221 — Advanced Intramedullary Nail System (December 21, 2022)
  • K220921 — Metal Bone Screw (December 12, 2022)
  • K172830 — Double Medical Femoral Nail System (August 24, 2018)
  • K172828 — Double Medical Cage System (February 1, 2018)

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)