Home / 510(k) Clearances / K201838

510(k) K201838

PediFlex Flexible Nail System by OrthoPediatrics Corp. — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2021
Date Received
July 2, 2020
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 OrthoPediatrics Corp.

  • K252600 — Pediatric Plating Platform I Small-Mini (October 9, 2025)
  • K251362 — PediFlex™ Flexible Nail System (June 24, 2025)
  • K243963 — Pediatric Plating Platform Hip (April 29, 2025)
  • K250623 — Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur (April 1, 2025)
  • K241816 — VerteGlide Spinal Growth Guidance System (March 14, 2025)
  • K243798 — Orthex External Fixation System (March 7, 2025)
  • K233105 — RESPONSE™ Rib and Pelvic System (January 20, 2024)
  • K231266 — Pediatric Nailing Platform Tibia (August 21, 2023)
  • K222105 — RESPONSE 5.5/6.0 Cannulated Screw System (March 23, 2023)
  • K223786 — Orthex External Fixation System (February 10, 2023)

Other clearances for product code HTY

  • K253325 — ZipToe™ Hammertoe Fusion System (December 29, 2025)
  • K252657 — Impact PEEK Union Nail System (September 19, 2025)
  • K250315 — RONAVIS – FX (FX-001) (August 1, 2025)
  • 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)