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FDA 510(k)

PEEK Spinal Infusion Cage

K-Number: K223776 · 2023-03-03

ApplicantChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Decision Date2023-03-03
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PEEK Spinal Infusion Cage is a medical device manufactured by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-03-03 under approval number K223776. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEEK Spinal Infusion Cage?

PEEK Spinal Infusion Cage is a medical device that received FDA 510(k) clearance on 2023-03-03. It is manufactured by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. The 510(k) number is K223776.

When was PEEK Spinal Infusion Cage approved by the FDA?

PEEK Spinal Infusion Cage received FDA 510(k) clearance on 2023-03-03, under approval number K223776.

What company makes PEEK Spinal Infusion Cage?

PEEK Spinal Infusion Cage is manufactured by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd..

What is the FDA product code for PEEK Spinal Infusion Cage?

The FDA product code for PEEK Spinal Infusion Cage is MAX.

Related Clinical Trials

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Official Source

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

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