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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 the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2016-03-16 under 510(k) 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. The listed applicant is Globus Medical, Inc.. The 510(k) number is K151665.

When did SUSTAIN Additional Implants receive FDA 510(k) clearance?

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

Who is the listed applicant for SUSTAIN Additional Implants?

The FDA 510(k) record lists Globus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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