FDA 510(k)

DigiFix Sterile Kit

K-Number: K192465 · 2019-10-10

Decision Date2019-10-10

Product CodeJEC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DigiFix Sterile Kit is a medical device manufactured by Virak Orthopedics, LLC. It received FDA 510(k) clearance on 2019-10-10 under approval number K192465. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DigiFix Sterile Kit?

DigiFix Sterile Kit is a medical device that received FDA 510(k) clearance on 2019-10-10. It is manufactured by Virak Orthopedics, LLC. The 510(k) number is K192465.

When was DigiFix Sterile Kit approved by the FDA?

DigiFix Sterile Kit received FDA 510(k) clearance on 2019-10-10, under approval number K192465.

What company makes DigiFix Sterile Kit?

DigiFix Sterile Kit is manufactured by Virak Orthopedics, LLC.

What is the FDA product code for DigiFix Sterile Kit?

The FDA product code for DigiFix Sterile Kit is JEC.

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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.