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510(k) K222105

RESPONSE 5.5/6.0 Cannulated Screw System by OrthoPediatrics Corp. — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2023
Date Received
July 18, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by OrthoPediatrics Corp.

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  • 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)
  • K223786 — Orthex External Fixation System (February 10, 2023)
  • K220679 — Pediatric Nailing Platform Femur (July 20, 2022)

Other clearances for product code NKB

  • K254247 — OSTEOMNI SPINAL FIXATION SYSTEM (February 24, 2026)
  • K253169 — Duet™ Spinal Fixation System (February 23, 2026)
  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252461 — Swedge™ Pedicle Screw Fixation System Bezier Rod (January 13, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)
  • K252729 — Universal Spinal System (November 18, 2025)
  • K253335 — CD Horizon™ Spinal System (October 24, 2025)