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FDA 510(k)

PRECICE Trauma Nail System

K-Number: K160267 · 2016-03-31

ApplicantEllipse Technologies, Incorporated
Decision Date2016-03-31
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRECICE Trauma Nail System is a medical device manufactured by Ellipse Technologies, Incorporated. It received FDA 510(k) clearance on 2016-03-31 under approval number K160267. 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 PRECICE Trauma Nail System?

PRECICE Trauma Nail System is a medical device that received FDA 510(k) clearance on 2016-03-31. It is manufactured by Ellipse Technologies, Incorporated. The 510(k) number is K160267.

When was PRECICE Trauma Nail System approved by the FDA?

PRECICE Trauma Nail System received FDA 510(k) clearance on 2016-03-31, under approval number K160267.

What company makes PRECICE Trauma Nail System?

PRECICE Trauma Nail System is manufactured by Ellipse Technologies, Incorporated.

What is the FDA product code for PRECICE Trauma Nail System?

The FDA product code for PRECICE Trauma Nail System is HSB.

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Other Devices by Ellipse Technologies, Incorporated

K151594Ellipse Supplemental Instrument Trays

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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