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510(k) K213281

PASS LP™ Spinal System, CD Horizon™ Spinal System by Medicrea International SA — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2022
Date Received
October 1, 2021
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 Medicrea International SA

  • K213659 — LigaPASS™ 2.0 Ligament Augmentation System (May 24, 2022)
  • K220810 — Infinity™ OCT System and PASS OCT Spinal System (April 19, 2022)
  • K220724 — CD Horizon™ Spinal System and PASS LP™ Spinal System (April 8, 2022)
  • K212005 — UNiD Spine Analyzer (January 12, 2022)
  • K210470 — C-CURVE Interbody Fusion Device (September 3, 2021)
  • K200316 — UNiD IB3D ALIF (October 30, 2020)
  • K191134 — IB3D ALIF (October 30, 2019)
  • K182158 — UNiD Patient-matched PLIF cage (July 15, 2019)
  • K190092 — UNiD Patient specific 3D printed TLIF cage (May 8, 2019)
  • K190376 — PASS LP Spinal System (May 2, 2019)

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)