Home GUDID 00840097534879 Ossera AFX
Primary DI 00840097534879
Brand Ossera AFX
Company Restor3d, Inc.
Model 1742-4242
Device description Ossera™ AFX, Pill, 42x42
Published 2026-08-14
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name HSB Rod, Fixation, Intramedullary And Accessories SAI Ankle Fusion Cage
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HSB Rod, Fixation, Intramedullary And Accessories Orthopedic 2 SAI Ankle Fusion Cage Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840097534879 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840097534879 00840097534879 840097534879 0840097534879
GMDN Terms# Term, Definition table Term Definition Metallic osteotomy fusion cage, non-customized A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia), or other bone (e.g., tarsal, carpel), following osteotomy to help facilitate bone fusion and alignment; it may be used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of metal [e.g., titanium (Ti)].
Regulatory Flags# DUNS number 080819836 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00193982471415 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982471439 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982471453 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982471477 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982471491 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982471514 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982471538 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982471767 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982471781 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982471804 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982471828 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982471842 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982471866 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982471880 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982472115 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982472139 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982472153 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982472177 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982472191 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982472214 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982472238 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982473822 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982473846 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982473860 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982473884 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982473907 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982473921 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982473945 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982474171 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14 00193982474195 AUTOBAHN GLOBUS MEDICAL, INC. HSB 2026-08-14