Home / 510(k) Clearances / K221332

510(k) K221332

OsteoCentric Spine MIS Pedicle Fastener System by OsteoCentric Technologies — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2022
Date Received
May 9, 2022
Clearance Type
Traditional
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 OsteoCentric Technologies

  • K250520 — OsteoCentric Navigated Instruments System (October 27, 2025)
  • K251913 — OsteoCentric® UnifiMI® TCS Plating System (August 16, 2025)
  • K250494 — The OsteoCentric Bone Plate and Screw System (March 18, 2025)
  • K242691 — OsteoCentric Technologies Cannulated Fasteners and Nuts (October 9, 2024)
  • K230242 — OsteoCentric Dental Implant System (October 5, 2023)
  • K230226 — Integrity-SI® Fusion System (September 21, 2023)
  • K230595 — OsteoCentric ACL Fixation System (June 29, 2023)
  • K230764 — OsteoCentric Integrated Hip Fastener System (April 18, 2023)
  • K222512 — Integrity-SI Fusion System (September 12, 2022)
  • K211290 — Cannulated Fasteners and Nuts (August 3, 2021)

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)