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510(k) K251850

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2025
Date Received
June 16, 2025
Clearance Type
Special
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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  • K250952 — Baby Gorilla®/Gorilla® Plating System (July 18, 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)

Other clearances for product code HSB

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  • K253591 — Phantom® Hindfoot TTC/TC Nail System (March 5, 2026)
  • K252025 — Active Intramedullary (AIM) Tibial Nail System (March 4, 2026)
  • K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (February 3, 2026)
  • K253749 — Affixus® Natural Nail® Proximal Humeral System (December 12, 2025)
  • K252826 — ARIX Femur Nail System (December 10, 2025)
  • K250197 — Estremo Fibular Nail (October 17, 2025)
  • K250628 — DynaNail TTC Fusion System (September 12, 2025)