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FDA 510(k)

Panta 2 Arthrodesis Nail System

K-Number: K181639 · 2018-11-02

ApplicantIntegra LifeSciences Corporation
Decision Date2018-11-02
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Panta 2 Arthrodesis Nail System is a medical device manufactured by Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2018-11-02 under approval number K181639. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Panta 2 Arthrodesis Nail System?

Panta 2 Arthrodesis Nail System is a medical device that received FDA 510(k) clearance on 2018-11-02. It is manufactured by Integra LifeSciences Corporation. The 510(k) number is K181639.

When was Panta 2 Arthrodesis Nail System approved by the FDA?

Panta 2 Arthrodesis Nail System received FDA 510(k) clearance on 2018-11-02, under approval number K181639.

What company makes Panta 2 Arthrodesis Nail System?

Panta 2 Arthrodesis Nail System is manufactured by Integra LifeSciences Corporation.

What is the FDA product code for Panta 2 Arthrodesis Nail System?

The FDA product code for Panta 2 Arthrodesis Nail System is HSB.

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Related Devices (Code: HSB)

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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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