FDA 510(k)

Metal Cannulated Screw

K-Number: K221090 · 2023-01-10

ApplicantDouble Medical Technology, Inc.

Decision Date2023-01-10

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Metal Cannulated Screw is the device name listed in this FDA 510(k) record. The listed applicant is Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2023-01-10 under 510(k) number K221090. 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 Metal Cannulated Screw?

Metal Cannulated Screw is a medical device that received FDA 510(k) clearance on 2023-01-10. The listed applicant is Double Medical Technology, Inc.. The 510(k) number is K221090.

When did Metal Cannulated Screw receive FDA 510(k) clearance?

Metal Cannulated Screw received FDA 510(k) clearance on 2023-01-10, under 510(k) number K221090.

Who is the listed applicant for Metal Cannulated Screw?

The FDA 510(k) record lists Double Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Metal Cannulated Screw?

The FDA product code for Metal Cannulated Screw is HWC. This falls under the Cardiovascular category.

Other records listing Double Medical Technology, Inc. as applicant

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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.