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510(k) K231292

TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System by Bonebridge AG — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2023
Date Received
May 4, 2023
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 Bonebridge AG

  • K252191 — BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System (December 17, 2025)
  • K250933 — LORRAINE 2.5/3.5mm Distal Humerus System (June 11, 2025)
  • K243308 — Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CA (December 20, 2024)
  • K242399 — Bonebridge Osteosynthesis Plating System (October 31, 2024)
  • K240318 — SITTER 3.5mm Versatile System (August 23, 2024)
  • K213864 — Bonebridge Osteosynthesis Plating System (September 2, 2022)
  • K203002 — SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle Syste (October 5, 2021)

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)