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FDA 510(k)

Virata Spinal Fixation System

K-Number: K250908 · 2025-06-18

ApplicantSeaSpine Orthopedics Corporation
Decision Date2025-06-18
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Virata Spinal Fixation System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2025-06-18 under approval number K250908. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Virata Spinal Fixation System?

Virata Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2025-06-18. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K250908.

When was Virata Spinal Fixation System approved by the FDA?

Virata Spinal Fixation System received FDA 510(k) clearance on 2025-06-18, under approval number K250908.

What company makes Virata Spinal Fixation System?

Virata Spinal Fixation System is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for Virata Spinal Fixation System?

The FDA product code for Virata Spinal Fixation System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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