Globus Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System, SCRIPT™ Implant System, AUTOBAHN™ Nailing System
172
Total
169
Cleared
0
Denied
FDA 510(k) Regulatory Record - Globus Medical, Inc. Orthopedic ✕
168 devices
Cleared
May 07, 2026
SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System,...
Orthopedic
164d
Cleared
Apr 29, 2026
SCRIPT™ Implant System
Orthopedic
211d
Cleared
Apr 24, 2026
AUTOBAHN™ Nailing System
Orthopedic
24d
Cleared
Feb 26, 2026
RIB LINK™ Fixation System
Orthopedic
231d
Cleared
Dec 22, 2025
HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)
Orthopedic
18d
Cleared
Nov 05, 2025
ExcelsiusGPS™ Instruments
Orthopedic
250d
Cleared
Aug 18, 2025
ANTHEM® Fracture System
Orthopedic
125d
Cleared
Jul 08, 2025
ExcelsiusXR™
Orthopedic
404d
Cleared
Jun 06, 2025
ONVOY™ Acetabular System
Orthopedic
211d
Cleared
Jan 10, 2025
NuVasive Pulse System
Orthopedic
30d
Cleared
Dec 20, 2024
ExcelsiusGPS® Instruments
Orthopedic
23d
Cleared
Dec 06, 2024
ACTIFY™ Unicondylar Knee System
Orthopedic
214d
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