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FDA 510(k)

EZStart Interference Screw

K-Number: K182955 · 2019-01-22

Decision Date2019-01-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EZStart Interference Screw is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2019-01-22 under approval number K182955. 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 EZStart Interference Screw?

EZStart Interference Screw is a medical device that received FDA 510(k) clearance on 2019-01-22. It is manufactured by Conmed Corporation. The 510(k) number is K182955.

When was EZStart Interference Screw approved by the FDA?

EZStart Interference Screw received FDA 510(k) clearance on 2019-01-22, under approval number K182955.

What company makes EZStart Interference Screw?

EZStart Interference Screw is manufactured by Conmed Corporation.

What is the FDA product code for EZStart Interference Screw?

The FDA product code for EZStart Interference Screw 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.