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FDA 510(k)

Cut Screw - Percutaneous Compression Screw

K-Number: K230397 · 2023-06-12

ApplicantGM Dos Reis Industria e Comercio Ltda.
Decision Date2023-06-12
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cut Screw - Percutaneous Compression Screw is the device name listed in this FDA 510(k) record. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2023-06-12 under 510(k) number K230397. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cut Screw - Percutaneous Compression Screw?

Cut Screw - Percutaneous Compression Screw is a medical device that received FDA 510(k) clearance on 2023-06-12. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K230397.

When did Cut Screw - Percutaneous Compression Screw receive FDA 510(k) clearance?

Cut Screw - Percutaneous Compression Screw received FDA 510(k) clearance on 2023-06-12, under 510(k) number K230397.

Who is the listed applicant for Cut Screw - Percutaneous Compression Screw?

The FDA 510(k) record lists GM Dos Reis Industria e Comercio Ltda. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cut Screw - Percutaneous Compression Screw?

The FDA product code for Cut Screw - Percutaneous Compression Screw is HWC. This falls under the Cardiovascular category.

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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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