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 a medical device manufactured by Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2024-12-04 under approval 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. It is manufactured by Double Medical Technology, Inc.. The 510(k) number is K242348.
When was Locking Screw,CoCrMo approved by the FDA?
Locking Screw,CoCrMo received FDA 510(k) clearance on 2024-12-04, under approval number K242348.
What company makes Locking Screw,CoCrMo?
Locking Screw,CoCrMo is manufactured by Double Medical Technology, Inc..
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.
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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.