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FDA 510(k)

DuraPro™ Oscillating System

K-Number: K240568 · 2024-04-29

ApplicantGlobus Medical, Inc.
Decision Date2024-04-29
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DuraPro™ Oscillating System 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 2024-04-29 under 510(k) number K240568. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DuraPro™ Oscillating System?

DuraPro™ Oscillating System is a medical device that received FDA 510(k) clearance on 2024-04-29. The listed applicant is Globus Medical, Inc.. The 510(k) number is K240568.

When did DuraPro™ Oscillating System receive FDA 510(k) clearance?

DuraPro™ Oscillating System received FDA 510(k) clearance on 2024-04-29, under 510(k) number K240568.

Who is the listed applicant for DuraPro™ Oscillating System?

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 DuraPro™ Oscillating System?

The FDA product code for DuraPro™ Oscillating System is OLO.

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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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