AUTOBAHN Nailing System— 510(k) K261043
Substantially EquivalentGlobus Medical, Inc.
FDA 510(k) clearance K261043 for AUTOBAHN Nailing System, Substantially Equivalent on 2026-04-24. Applicant: Globus Medical, Inc.. Device class: 2.
Summary
Globus Medical's AUTOBAHN Nailing System is filed under product code HSB (Rod, Fixation, Intramedullary And Accessories).
Class II, 21 CFR 888.3020. Orthopedic is both the classification panel and the review panel. It came in as a Special 510(k).
Globus Medical filed from Audubon, Pennsylvania. The record shows 24 calendar days from receipt to decision (March 31 to April 24, 2026).
Clearance details
- Applicant
- Globus Medical, Inc.
- Product code
- Product code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Audubon, PA, US
Recent devices under product code HSB
view allMore clearances from Globus Medical, Inc.
view all- K262779 — ANTHEM Fracture System
- K254043 — TRIVANCE Hip Stem
- K262251 — ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)
- K253739 — SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System
- K253401 — SCRIPT Implant System
Adverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.