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510(k) K232566

NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System by SeaSpine Orthopedics Corporation — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2024
Date Received
August 24, 2023
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 SeaSpine Orthopedics Corporation

  • K250908 — Virata Spinal Fixation System (June 18, 2025)
  • K243659 — FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments (April 2, 2025)
  • K242273 — Cove Putty, OsteoCove Putty (September 25, 2024)
  • K241466 — Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral S (June 20, 2024)
  • K240566 — Reef L Interbody System; WaveForm L Interbody System (April 26, 2024)
  • K233694 — Meridian Interbody System; WaveForm A Interbody System (January 12, 2024)
  • K233414 — Shoreline ACS Interbody System; Shoreline RT Interbody System (November 28, 2023)
  • K232668 — Cove Strip, OsteoCove Strip (September 27, 2023)
  • K231030 — Cove Putty, OsteoCove Putty (September 14, 2023)
  • K230486 — Cove Strip (August 21, 2023)

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)