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FDA 510(k)

Cannulated Headless Bone Screws

K-Number: K233008 · 2024-06-05

ApplicantAap Implantate AG
Decision Date2024-06-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cannulated Headless Bone Screws is the device name listed in this FDA 510(k) record. The listed applicant is Aap Implantate AG. It received FDA 510(k) clearance on 2024-06-05 under 510(k) number K233008. 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 Cannulated Headless Bone Screws?

Cannulated Headless Bone Screws is a medical device that received FDA 510(k) clearance on 2024-06-05. The listed applicant is Aap Implantate AG. The 510(k) number is K233008.

When did Cannulated Headless Bone Screws receive FDA 510(k) clearance?

Cannulated Headless Bone Screws received FDA 510(k) clearance on 2024-06-05, under 510(k) number K233008.

Who is the listed applicant for Cannulated Headless Bone Screws?

The FDA 510(k) record lists Aap Implantate AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cannulated Headless Bone Screws?

The FDA product code for Cannulated Headless Bone Screws is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

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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