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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 a medical device manufactured by Aap Implantate AG. It received FDA 510(k) clearance on 2024-06-05 under approval 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. It is manufactured by Aap Implantate AG. The 510(k) number is K233008.

When was Cannulated Headless Bone Screws approved by the FDA?

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

What company makes Cannulated Headless Bone Screws?

Cannulated Headless Bone Screws is manufactured by Aap Implantate AG.

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.

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Related Devices (Code: HWC)

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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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