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FDA 510(k)

OsteoCentric Technologies Cannulated Fasteners and Nuts

K-Number: K242691 · 2024-10-09

ApplicantOsteoCentric Technologies
Decision Date2024-10-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoCentric Technologies Cannulated Fasteners and Nuts is a medical device manufactured by OsteoCentric Technologies. It received FDA 510(k) clearance on 2024-10-09 under approval number K242691. 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 OsteoCentric Technologies Cannulated Fasteners and Nuts?

OsteoCentric Technologies Cannulated Fasteners and Nuts is a medical device that received FDA 510(k) clearance on 2024-10-09. It is manufactured by OsteoCentric Technologies. The 510(k) number is K242691.

When was OsteoCentric Technologies Cannulated Fasteners and Nuts approved by the FDA?

OsteoCentric Technologies Cannulated Fasteners and Nuts received FDA 510(k) clearance on 2024-10-09, under approval number K242691.

What company makes OsteoCentric Technologies Cannulated Fasteners and Nuts?

OsteoCentric Technologies Cannulated Fasteners and Nuts is manufactured by OsteoCentric Technologies.

What is the FDA product code for OsteoCentric Technologies Cannulated Fasteners and Nuts?

The FDA product code for OsteoCentric Technologies Cannulated Fasteners and Nuts 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.

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