FDA 510(k)

Locking Screw,CoCrMo

K-Number: K242348 · 2024-12-04

ApplicantDouble Medical Technology, Inc.

Decision Date2024-12-04

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Locking Screw,CoCrMo 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 2024-12-04 under 510(k) number K242348. 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 Locking Screw,CoCrMo?

Locking Screw,CoCrMo is a medical device that received FDA 510(k) clearance on 2024-12-04. The listed applicant is Double Medical Technology, Inc.. The 510(k) number is K242348.

When did Locking Screw,CoCrMo receive FDA 510(k) clearance?

Locking Screw,CoCrMo received FDA 510(k) clearance on 2024-12-04, under 510(k) number K242348.

Who is the listed applicant for Locking Screw,CoCrMo?

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 Locking Screw,CoCrMo?

The FDA product code for Locking Screw,CoCrMo 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.