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FDA 510(k)

REDUCT® Headless Compression Screw System

K-Number: K201662 · 2020-07-16

ApplicantSkeletal Dynamics, Inc.
Decision Date2020-07-16
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REDUCT® Headless Compression Screw System is a medical device manufactured by Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2020-07-16 under approval number K201662. 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 REDUCT® Headless Compression Screw System?

REDUCT® Headless Compression Screw System is a medical device that received FDA 510(k) clearance on 2020-07-16. It is manufactured by Skeletal Dynamics, Inc.. The 510(k) number is K201662.

When was REDUCT® Headless Compression Screw System approved by the FDA?

REDUCT® Headless Compression Screw System received FDA 510(k) clearance on 2020-07-16, under approval number K201662.

What company makes REDUCT® Headless Compression Screw System?

REDUCT® Headless Compression Screw System is manufactured by Skeletal Dynamics, Inc..

What is the FDA product code for REDUCT® Headless Compression Screw System?

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

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Other Devices by Skeletal Dynamics, Inc.

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Related Devices (Code: HWC)

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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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