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FDA 510(k)

OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm

K-Number: K221193 · 2022-12-23

ApplicantOSSIO , Ltd.
Decision Date2022-12-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm is a medical device manufactured by OSSIO , Ltd.. It received FDA 510(k) clearance on 2022-12-23 under approval number K221193. 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 OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm?

OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm is a medical device that received FDA 510(k) clearance on 2022-12-23. It is manufactured by OSSIO , Ltd.. The 510(k) number is K221193.

When was OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm approved by the FDA?

OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm received FDA 510(k) clearance on 2022-12-23, under approval number K221193.

What company makes OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm?

OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm is manufactured by OSSIO , Ltd..

What is the FDA product code for OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm?

The FDA product code for OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm 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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