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FDA 510(k)

SUSTAIN Additional Implants

K-Number: K151665 · 2016-03-16

ApplicantGlobus Medical, Inc.
Decision Date2016-03-16
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUSTAIN Additional Implants is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2016-03-16 under approval number K151665. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUSTAIN Additional Implants?

SUSTAIN Additional Implants is a medical device that received FDA 510(k) clearance on 2016-03-16. It is manufactured by Globus Medical, Inc.. The 510(k) number is K151665.

When was SUSTAIN Additional Implants approved by the FDA?

SUSTAIN Additional Implants received FDA 510(k) clearance on 2016-03-16, under approval number K151665.

What company makes SUSTAIN Additional Implants?

SUSTAIN Additional Implants is manufactured by Globus Medical, Inc..

What is the FDA product code for SUSTAIN Additional Implants?

The FDA product code for SUSTAIN Additional Implants is MAX.

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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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