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510(k) K240388

Osteotomy Truss System (OTS) by 4Web Medical, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2024
Date Received
February 8, 2024
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 4Web Medical, Inc.

  • K252834 — Sacroiliac Joint Truss System (SJTS) (January 28, 2026)
  • K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA) (December 11, 2025)
  • K251117 — Cervical Spine Truss System (CSTS) (April 25, 2025)
  • K233966 — Anterior Spine Truss System-Stand Alone (ASTS-SA) (April 22, 2024)
  • K230088 — Ankle Truss System (ATS) (March 21, 2024)
  • K231739 — Cervical Spine Truss System (CSTS) (September 25, 2023)
  • K223362 — Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device (February 2, 2023)
  • K221266 — Cervical Spine Truss System (CSTS) Interbody Fusion Device (January 5, 2023)
  • K221283 — Hammertoe Truss System (HTS) (September 6, 2022)
  • K220463 — Osteotomy Truss System (OTS) (May 18, 2022)

Other clearances for product code HRS

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  • 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)