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FDA 510(k)

SABLE Expandable Spacer

K-Number: K192115 · 2020-01-14

ApplicantGlobus Medical, Inc.
Decision Date2020-01-14
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SABLE Expandable Spacer 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 2020-01-14 under 510(k) number K192115. 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 SABLE Expandable Spacer?

SABLE Expandable Spacer is a medical device that received FDA 510(k) clearance on 2020-01-14. The listed applicant is Globus Medical, Inc.. The 510(k) number is K192115.

When did SABLE Expandable Spacer receive FDA 510(k) clearance?

SABLE Expandable Spacer received FDA 510(k) clearance on 2020-01-14, under 510(k) number K192115.

Who is the listed applicant for SABLE Expandable Spacer?

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 SABLE Expandable Spacer?

The FDA product code for SABLE Expandable Spacer 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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