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510(k) K211646

FINE Osteotomy by Bodycad Laboratories, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2021
Date Received
May 28, 2021
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 Bodycad Laboratories, Inc.

  • K253300 — Fine Osteotomy™ (October 28, 2025)
  • K250394 — Fine TTO™ (October 21, 2025)
  • K250923 — Fine Osteotomy™ (August 21, 2025)
  • K241356 — Fine Osteotomy™ (September 5, 2024)
  • K240703 — Fine Osteotomy™ (April 12, 2024)
  • K240066 — Fine Osteotomy™ (February 9, 2024)
  • K231314 — Fine Osteotomy™ (June 2, 2023)
  • K212307 — BC Reflex Uni Knee System (October 12, 2021)
  • K211895 — BC Reflex Uni Knee System (August 20, 2021)
  • K203697 — BC Reflex Uni Knee System (March 12, 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)