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FDA 510(k)

CALIBER SPACERS

K-Number: K123231 · 2013-01-18

ApplicantGlobus Medical, Inc.
Decision Date2013-01-18
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CALIBER 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 2013-01-18 under 510(k) number K123231. 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 CALIBER SPACERS?

CALIBER SPACERS is a medical device that received FDA 510(k) clearance on 2013-01-18. The listed applicant is Globus Medical, Inc.. The 510(k) number is K123231.

When did CALIBER SPACERS receive FDA 510(k) clearance?

CALIBER SPACERS received FDA 510(k) clearance on 2013-01-18, under 510(k) number K123231.

Who is the listed applicant for CALIBER 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 CALIBER SPACERS?

The FDA product code for CALIBER 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.

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