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510(k) K253591

Phantom® Hindfoot TTC/TC Nail System by Paragon 28, Inc. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2026
Date Received
November 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

Other clearances by Paragon 28, Inc.

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  • K251862 — External Fixation Bone Distractor (August 11, 2025)
  • K250952 — Baby Gorilla®/Gorilla® Plating System (July 18, 2025)
  • K251850 — Phantom® Hindfoot TTC/TC Nail System (July 14, 2025)
  • K250641 — APEX 3D Total Ankle Replacement System (May 1, 2025)
  • K242452 — Monkey Bars Pin to Bar External Fixation System (November 1, 2024)
  • K234128 — Phantom Fibula Nail System (August 22, 2024)
  • K241864 — Grappler Interference Screw System (July 25, 2024)
  • K240259 — APEX 3D Total Ankle Replacement System (June 24, 2024)

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  • K250628 — DynaNail TTC Fusion System (September 12, 2025)
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