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510(k) K260291

Vortex5 Tailor's Bunion Correction System by Nvision Biomedical Technologies, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2026
Date Received
January 29, 2026
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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  • K250646 — Impact PEEK Union Nail System (June 11, 2025)
  • 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)

Other clearances for product code HRS

  • K260090 — SMART Osteotomy System (April 10, 2026)
  • K253718 — enHAnce PEEK Bunion System (April 1, 2026)
  • K260274 — Airlock® Ankle Plating System (March 25, 2026)
  • K254253 — LOQTEQ® VA Proximal Humerus Plate 3.5 (March 24, 2026)
  • K254288 — Clavicle Fixation System (March 23, 2026)
  • K260448 — CastleLoc Pectus Bar System (March 19, 2026)
  • K260390 — Super Upper Limbs Versalock Plating System (March 17, 2026)
  • K254053 — APS Spear Locking Plate (March 17, 2026)
  • K253916 — APTUS Shoulder Proximal Humerus System, PentaLock 3.5 (March 16, 2026)
  • K253906 — Xpert Hand (March 11, 2026)