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FDA 510(k)

Kodiak Spinal Fixation System

K-Number: K181677 · 2018-08-09

ApplicantAlphatec Spine, Inc.
Decision Date2018-08-09
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Kodiak Spinal Fixation System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2018-08-09 under approval number K181677. 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 Kodiak Spinal Fixation System?

Kodiak Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2018-08-09. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K181677.

When was Kodiak Spinal Fixation System approved by the FDA?

Kodiak Spinal Fixation System received FDA 510(k) clearance on 2018-08-09, under approval number K181677.

What company makes Kodiak Spinal Fixation System?

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

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

The FDA product code for Kodiak 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)

Other Devices by Alphatec Spine, Inc.

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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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