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510(k) K231496

TITAN 3-D Wedge System by Paragon 28, Inc. — Product Code PLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2023
Date Received
May 24, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Wedge
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.

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Other clearances for product code PLF

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  • K240461 — OsteoSinter® EVANS and COTTON wedges and related accessories (December 6, 2024)
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  • K234116 — Trigon Trigon HA Stand-Alone Wedge Fixation System (January 26, 2024)
  • K223226 — Trigon™ HA Stand-Alone Wedge Fixation System (December 1, 2022)
  • K220197 — Trigon HA Wedge Fixation System (February 23, 2022)
  • K201314 — Restor3d Utility Wedge (June 17, 2021)
  • K203445 — Trigon HA Stand-Alone Wedge Fixation System (December 21, 2020)