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510(k) K221283

Hammertoe Truss System (HTS) by 4Web Medical, Inc. — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2022
Date Received
May 3, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
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)
  • K240388 — Osteotomy Truss System (OTS) (November 1, 2024)
  • 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)
  • K220463 — Osteotomy Truss System (OTS) (May 18, 2022)

Other clearances for product code HTY

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  • K251362 — PediFlex™ Flexible Nail System (June 24, 2025)
  • K250646 — Impact PEEK Union Nail System (June 11, 2025)
  • K241014 — Biomet Kirschner Wires (K-Wires) (May 22, 2024)
  • K231272 — OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimm (December 1, 2023)
  • K231147 — Hammerdesis™ Interphalangeal Fusion System (September 14, 2023)
  • K230750 — OSSIOfiber® Cannulated Trimmable Fixation Nail (September 13, 2023)
  • K231905 — Electro-Spec Steri-Caps (August 14, 2023)