FDA 510(k)

Haymaker® Screw System

K-Number: K222799 · 2023-01-10

ApplicantOrthocircle Spine D.B.A. OC Medical Devices

Decision Date2023-01-10

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Haymaker® Screw System is a medical device manufactured by Orthocircle Spine D.B.A. OC Medical Devices. It received FDA 510(k) clearance on 2023-01-10 under approval number K222799. 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 Haymaker® Screw System?

Haymaker® Screw System is a medical device that received FDA 510(k) clearance on 2023-01-10. It is manufactured by Orthocircle Spine D.B.A. OC Medical Devices. The 510(k) number is K222799.

When was Haymaker® Screw System approved by the FDA?

Haymaker® Screw System received FDA 510(k) clearance on 2023-01-10, under approval number K222799.

What company makes Haymaker® Screw System?

Haymaker® Screw System is manufactured by Orthocircle Spine D.B.A. OC Medical Devices.

What is the FDA product code for Haymaker® Screw System?

The FDA product code for Haymaker® Screw System is HWC. This falls under the Cardiovascular category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.