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FDA 510(k)

Cannulated Fasteners and Nuts

K-Number: K211290 · 2021-08-03

ApplicantOsteoCentric Technologies
Decision Date2021-08-03
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cannulated Fasteners and Nuts is a medical device manufactured by OsteoCentric Technologies. It received FDA 510(k) clearance on 2021-08-03 under approval number K211290. 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 Fasteners and Nuts?

Cannulated Fasteners and Nuts is a medical device that received FDA 510(k) clearance on 2021-08-03. It is manufactured by OsteoCentric Technologies. The 510(k) number is K211290.

When was Cannulated Fasteners and Nuts approved by the FDA?

Cannulated Fasteners and Nuts received FDA 510(k) clearance on 2021-08-03, under approval number K211290.

What company makes Cannulated Fasteners and Nuts?

Cannulated Fasteners and Nuts is manufactured by OsteoCentric Technologies.

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

The FDA product code for 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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