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510(k) K162674

BioPro Foot Plating Systems by Biopro, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2017
Date Received
September 26, 2016
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 Biopro, Inc.

  • K163627 — Shotel Ankle Arthrodesis Nail System (September 14, 2017)
  • K132510 — BIOPRO - INFINITY PLATE ANCHOR SYSTEM (October 24, 2013)
  • K130298 — BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM (June 18, 2013)
  • K121973 — BIOPRO HEMI-EDGE TOE SYSTEM (October 30, 2012)
  • K100761 — BIOPRO POLAR HEAD (December 3, 2010)
  • K101030 — MODIFICATION TO HBS HEADLESS BONE SCREW (June 3, 2010)
  • K090208 — BIOPRO FEMORAL HEADS (May 22, 2009)
  • K083490 — BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 (March 18, 2009)
  • K082705 — BIOPRO BIPOLAR HEAD, MODELS 18130-18152 (December 15, 2008)
  • K081149 — BIOPRO GO-EZ SCREW (August 5, 2008)

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  • 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)