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FDA 510(k)

AUTOBAHN™ Nailing System

K-Number: K261043 · 2026-04-24

ApplicantGlobus Medical, Inc.
Decision Date2026-04-24
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AUTOBAHN™ Nailing System is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2026-04-24 under approval number K261043. 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™ Nailing System?

AUTOBAHN™ Nailing System is a medical device that received FDA 510(k) clearance on 2026-04-24. It is manufactured by Globus Medical, Inc.. The 510(k) number is K261043.

When was AUTOBAHN™ Nailing System approved by the FDA?

AUTOBAHN™ Nailing System received FDA 510(k) clearance on 2026-04-24, under approval number K261043.

What company makes AUTOBAHN™ Nailing System?

AUTOBAHN™ Nailing System is manufactured by Globus Medical, Inc..

What is the FDA product code for AUTOBAHN™ Nailing System?

The FDA product code for AUTOBAHN™ Nailing System is HSB.

Related Clinical Trials

NCT04015128 A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT ACTIVE_NOT_RECRUITING NCT04015154 A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF COMPLETED

Other Devices by Globus Medical, Inc.

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Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

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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