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FDA 510(k)

Arsenal Spinal Fixation System

K-Number: K161363 · 2016-06-10

ApplicantAlphatec Spine, Inc.
Decision Date2016-06-10
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arsenal Spinal Fixation System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2016-06-10 under approval number K161363. 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 Arsenal Spinal Fixation System?

Arsenal Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2016-06-10. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K161363.

When was Arsenal Spinal Fixation System approved by the FDA?

Arsenal Spinal Fixation System received FDA 510(k) clearance on 2016-06-10, under approval number K161363.

What company makes Arsenal Spinal Fixation System?

Arsenal Spinal Fixation System is manufactured by Alphatec Spine, Inc..

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

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

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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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Related Devices (Code: NKB)

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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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