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510(k) K202657

Javelin Tailor's Bunion Fixation System by Nvision Biomedical Technologies, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2020
Date Received
September 14, 2020
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 Nvision Biomedical Technologies, Inc.

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  • K250613 — SnapHammer Hammertoe Correction System (April 2, 2025)
  • K242896 — Caliber Intramedullary Fixation System (February 5, 2025)
  • K243231 — Trigon PEEK HA Wedges (November 8, 2024)
  • K240250 — 3D Printed PEEK Interbody System (September 17, 2024)
  • K231453 — SnapHammer Hammertoe Correction System (February 16, 2024)
  • K234116 — Trigon Trigon HA Stand-Alone Wedge Fixation System (January 26, 2024)
  • K230853 — EARP Nerve Cuff Electrode (October 6, 2023)

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  • 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)
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