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FDA 510(k)

PYTHON Plate Trial Instruments

K-Number: K173930 · 2018-03-19

ApplicantTreace Medical Concepts, Inc.
Decision Date2018-03-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PYTHON Plate Trial Instruments is a medical device manufactured by Treace Medical Concepts, Inc.. It received FDA 510(k) clearance on 2018-03-19 under approval number K173930. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PYTHON Plate Trial Instruments?

PYTHON Plate Trial Instruments is a medical device that received FDA 510(k) clearance on 2018-03-19. It is manufactured by Treace Medical Concepts, Inc.. The 510(k) number is K173930.

When was PYTHON Plate Trial Instruments approved by the FDA?

PYTHON Plate Trial Instruments received FDA 510(k) clearance on 2018-03-19, under approval number K173930.

What company makes PYTHON Plate Trial Instruments?

PYTHON Plate Trial Instruments is manufactured by Treace Medical Concepts, Inc..

What is the FDA product code for PYTHON Plate Trial Instruments?

The FDA product code for PYTHON Plate Trial Instruments is HRS.

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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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