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FDA 510(k)

COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS

K-Number: K173115 · 2017-12-20

ApplicantGlobus Medical, Inc.
Decision Date2017-12-20
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2017-12-20 under approval number K173115. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS?

COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS is a medical device that received FDA 510(k) clearance on 2017-12-20. It is manufactured by Globus Medical, Inc.. The 510(k) number is K173115.

When was COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS approved by the FDA?

COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS received FDA 510(k) clearance on 2017-12-20, under approval number K173115.

What company makes COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS?

COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS is manufactured by Globus Medical, Inc..

What is the FDA product code for COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS?

The FDA product code for COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS is ODP.

Other Devices by Globus Medical, Inc.

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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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