FDA 510(k)

SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS

K-Number: K130478 · 2013-07-26

Decision Date2013-07-26

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS 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 2013-07-26 under 510(k) number K130478. 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 AND SUSTAIN RADIOLUCENT SPACERS?

SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS is a medical device that received FDA 510(k) clearance on 2013-07-26. The listed applicant is Globus Medical, Inc.. The 510(k) number is K130478.

When did SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS receive FDA 510(k) clearance?

SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS received FDA 510(k) clearance on 2013-07-26, under 510(k) number K130478.

Who is the listed applicant for SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS?

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 AND SUSTAIN RADIOLUCENT SPACERS?

The FDA product code for SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS 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.