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FDA 510(k)

AnyPlus II Spinal Fixation System

K-Number: K240350 · 2024-04-03

ApplicantGS Medical Co., Ltd.
Decision Date2024-04-03
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AnyPlus II Spinal Fixation System is a medical device manufactured by GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-04-03 under approval number K240350. 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 AnyPlus II Spinal Fixation System?

AnyPlus II Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2024-04-03. It is manufactured by GS Medical Co., Ltd.. The 510(k) number is K240350.

When was AnyPlus II Spinal Fixation System approved by the FDA?

AnyPlus II Spinal Fixation System received FDA 510(k) clearance on 2024-04-03, under approval number K240350.

What company makes AnyPlus II Spinal Fixation System?

AnyPlus II Spinal Fixation System is manufactured by GS Medical Co., Ltd..

What is the FDA product code for AnyPlus II Spinal Fixation System?

The FDA product code for AnyPlus II 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 GS Medical Co., Ltd.

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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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