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FDA 510(k)

AUTOBAHN(R) EVO Femoral Nails

K-Number: K220659 · 2022-09-09

Decision Date2022-09-09
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AUTOBAHN(R) EVO Femoral Nails is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2022-09-09 under approval 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. It is manufactured by Globus Medical, Inc.. The 510(k) number is K220659.

When was AUTOBAHN(R) EVO Femoral Nails approved by the FDA?

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

What company makes AUTOBAHN(R) EVO Femoral Nails?

AUTOBAHN(R) EVO Femoral Nails is manufactured by Globus Medical, Inc..

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.