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FDA 510(k)

AUTOBAHN(R) EVO Femoral Nails

K-Number: K220659 · 2022-09-09

ApplicantGlobus Medical, Inc.
Decision Date2022-09-09
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AUTOBAHN(R) EVO Femoral Nails 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 2022-09-09 under 510(k) number K220659. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOBAHN(R) EVO Femoral Nails?

AUTOBAHN(R) EVO Femoral Nails is a medical device that received FDA 510(k) clearance on 2022-09-09. The listed applicant is Globus Medical, Inc.. The 510(k) number is K220659.

When did AUTOBAHN(R) EVO Femoral Nails receive FDA 510(k) clearance?

AUTOBAHN(R) EVO Femoral Nails received FDA 510(k) clearance on 2022-09-09, under 510(k) number K220659.

Who is the listed applicant for AUTOBAHN(R) EVO Femoral Nails?

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 AUTOBAHN(R) EVO Femoral Nails?

The FDA product code for AUTOBAHN(R) EVO Femoral Nails is HSB.

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Related Devices (Code: HSB)

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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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