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FDA 510(k)

4CIS® Pinehurst Anterior Cervical Plate system

K-Number: K182489 · 2019-01-16

ApplicantSolco Biomedical Co., Ltd.
Decision Date2019-01-16
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

4CIS® Pinehurst Anterior Cervical Plate system is a medical device manufactured by Solco Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2019-01-16 under approval number K182489. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4CIS® Pinehurst Anterior Cervical Plate system?

4CIS® Pinehurst Anterior Cervical Plate system is a medical device that received FDA 510(k) clearance on 2019-01-16. It is manufactured by Solco Biomedical Co., Ltd.. The 510(k) number is K182489.

When was 4CIS® Pinehurst Anterior Cervical Plate system approved by the FDA?

4CIS® Pinehurst Anterior Cervical Plate system received FDA 510(k) clearance on 2019-01-16, under approval number K182489.

What company makes 4CIS® Pinehurst Anterior Cervical Plate system?

4CIS® Pinehurst Anterior Cervical Plate system is manufactured by Solco Biomedical Co., Ltd..

What is the FDA product code for 4CIS® Pinehurst Anterior Cervical Plate system?

The FDA product code for 4CIS® Pinehurst Anterior Cervical Plate system is KWQ.

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Related Devices (Code: KWQ)

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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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