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FDA 510(k)

Healix™ Compression Screw System

K-Number: K182949 · 2018-12-04

ApplicantNvision Biomedical Technologies, LLC
Decision Date2018-12-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Healix™ Compression Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2018-12-04 under 510(k) number K182949. 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 Healix™ Compression Screw System?

Healix™ Compression Screw System is a medical device that received FDA 510(k) clearance on 2018-12-04. The listed applicant is Nvision Biomedical Technologies, LLC. The 510(k) number is K182949.

When did Healix™ Compression Screw System receive FDA 510(k) clearance?

Healix™ Compression Screw System received FDA 510(k) clearance on 2018-12-04, under 510(k) number K182949.

Who is the listed applicant for Healix™ Compression Screw System?

The FDA 510(k) record lists Nvision Biomedical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Healix™ Compression Screw System?

The FDA product code for Healix™ Compression Screw System 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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