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510(k) K250908

Virata Spinal Fixation System by SeaSpine Orthopedics Corporation — Product Code NKB

K250908 is an FDA 510(k) premarket notification submitted by SeaSpine Orthopedics Corporation for the device "Virata Spinal Fixation System". The FDA issued a decision of Substantially Equivalent on June 18, 2025. 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2025
Date Received
March 26, 2025
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

  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • 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)
  • K232566 — NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System (April 19, 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)

Other clearances for product code NKB

  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy (July 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (July 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (June 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (June 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)
  • K253739 — SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® (May 7, 2026)
  • K261130 — AccelFix Spinal Fixation System (May 5, 2026)
  • K253966 — PERLA® TL Posterior Thoraco-lumbar Fixation System (May 1, 2026)
  • K252542 — LEO Spinal System (April 29, 2026)
  • K253940 — M.U.S.T. Pedicle Screw System - Extension (April 28, 2026)

FDA data resources