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FDA 510(k)

Mini Cannulated Headed and Headless Screw Set

K-Number: K183104 · 2019-06-10

ApplicantStryker GmbH
Decision Date2019-06-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mini Cannulated Headed and Headless Screw Set is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2019-06-10 under 510(k) number K183104. 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 Mini Cannulated Headed and Headless Screw Set?

Mini Cannulated Headed and Headless Screw Set is a medical device that received FDA 510(k) clearance on 2019-06-10. The listed applicant is Stryker GmbH. The 510(k) number is K183104.

When did Mini Cannulated Headed and Headless Screw Set receive FDA 510(k) clearance?

Mini Cannulated Headed and Headless Screw Set received FDA 510(k) clearance on 2019-06-10, under 510(k) number K183104.

Who is the listed applicant for Mini Cannulated Headed and Headless Screw Set?

The FDA 510(k) record lists Stryker GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mini Cannulated Headed and Headless Screw Set?

The FDA product code for Mini Cannulated Headed and Headless Screw Set 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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