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510(k) K191648

Mariner MIS Pedicle Screw System; SeaSpine Navigation System by SeaSpine Orthopedics Corporation — Product Code NKB

K191648 is an FDA 510(k) premarket notification submitted by SeaSpine Orthopedics Corporation for the device "Mariner MIS Pedicle Screw System; SeaSpine Navigation System". The FDA issued a decision of Substantially Equivalent on Jul 19, 2019. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. SeaSpine Orthopedics Corporation has 66 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 19, 2019
Date Received
Jun 20, 2019
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
510(k)

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

  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF… (Jul 1, 2026)
  • K250908 — Virata Spinal Fixation System (Jun 18, 2025)
  • K243659 — FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments (Apr 2, 2025)
  • K242273 — Cove Putty, OsteoCove Putty (Sep 25, 2024)
  • K241466 — Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral… (Jun 20, 2024)
  • K240566 — Reef L Interbody System; WaveForm L Interbody System (Apr 26, 2024)
  • K232566 — NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal… (Apr 19, 2024)
  • K233694 — Meridian Interbody System; WaveForm A Interbody System (Jan 12, 2024)
  • K233414 — Shoreline ACS Interbody System; Shoreline RT Interbody System (Nov 28, 2023)
  • K232668 — Cove Strip, OsteoCove Strip (Sep 27, 2023)

Other clearances for product code NKB

  • K262091 — FRAXION Spinal Fixation System (Sep 17, 2026)
  • K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor… (Sep 14, 2026)
  • K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (Sep 4, 2026)
  • K253943 — Tiger 2 System (Jul 24, 2026)
  • K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS… (Jul 24, 2026)
  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation… (Jul 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (Jul 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (Jun 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (Jun 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)

FDA data resources