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510(k) K151921

STERISPINE PS by Safe Orthopaedics — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2015
Date Received
July 13, 2015
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 Safe Orthopaedics

  • K201648 — Sterispine™ PS (July 30, 2020)
  • K170528 — Sterispine™ PS (March 9, 2017)
  • K162531 — STERISPINE CC (December 29, 2016)
  • K151747 — STERISPINE PS (October 5, 2015)
  • K151756 — STERISPINE LC CAGE (August 21, 2015)
  • K150092 — STERISPINE PS Pedicle Screw (February 10, 2015)
  • K140802 — STERISPINE PS (June 4, 2014)
  • K133893 — STERISPINE LC CAGE (March 14, 2014)
  • K130632 — STERISPINE PS PEDICLE SCREW (May 3, 2013)
  • K122021 — STERISPINE LC CAGE (September 20, 2012)

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)