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FDA 510(k)

Orthopeasia Spinal Fixation System

K-Number: K240180 · 2024-08-30

ApplicantOrthopeasia Co., Ltd.
Decision Date2024-08-30
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Orthopeasia Spinal Fixation System is a medical device manufactured by Orthopeasia Co., Ltd.. It received FDA 510(k) clearance on 2024-08-30 under approval number K240180. 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 Orthopeasia Spinal Fixation System?

Orthopeasia Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2024-08-30. It is manufactured by Orthopeasia Co., Ltd.. The 510(k) number is K240180.

When was Orthopeasia Spinal Fixation System approved by the FDA?

Orthopeasia Spinal Fixation System received FDA 510(k) clearance on 2024-08-30, under approval number K240180.

What company makes Orthopeasia Spinal Fixation System?

Orthopeasia Spinal Fixation System is manufactured by Orthopeasia Co., Ltd..

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

The FDA product code for Orthopeasia 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)

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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