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510(k) K190926

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2019
Date Received
April 9, 2019
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

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  • K171351 — Posterior Spine Truss System (PSTS) Interbody Fusion Device (September 8, 2017)
  • K170851 — Anterior Spine Truss System (STS) Interbody Fusion Device (August 7, 2017)
  • K153436 — LATERAL Spine Truss System (June 6, 2016)

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