Home GUDID 00810204090468 Tailored-C Cervical Interbody Fusion System
Primary DI 00810204090468
Brand Tailored-C Cervical Interbody Fusion System
Company Demetra, Inc.
Model BC7-1416-9
Device description ANTERIOR CERVICAL 3DTI IMPLANT 14x16x9MM - 7°
Published 2026-09-30
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 false Product Codes# Code, Name table Code Name ODP Intervertebral Fusion Device With Bone Graft, Cervical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810204090468 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 00810204090468 00810204090468 810204090468 0810204090468
GMDN Terms# Term, Definition table Term Definition Metallic spinal interbody fusion cage A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.
Regulatory Flags# DUNS number 119561472 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810204090017 Tailored-H Cervical Standalone System BCS7-1416-6 2026-09-30 00810204090024 Tailored-H Cervical Standalone System BCS7-1416-7 2026-09-30 00810204090031 Tailored-H Cervical Standalone System BCS7-1416-8 2026-09-30 00810204090048 Tailored-H Cervical Standalone System BCS7-1416-9 2026-09-30 00810204090055 Tailored-H Cervical Standalone System BCS7-1416-10 2026-09-30 00810204090062 Tailored-H Cervical Standalone System BCS12-1416-6 2026-09-30 00810204090079 Tailored-H Cervical Standalone System BCS12-1416-7 2026-09-30 00810204090086 Tailored-H Cervical Standalone System BCS12-1416-8 2026-09-30 00810204090093 Tailored-H Cervical Standalone System BCS12-1416-9 2026-09-30 00810204090109 Tailored-H Cervical Standalone System BCS12-1416-10 2026-09-30 00810204090116 Tailored-H Cervical Standalone System BCSD-3512 2026-09-30 00810204090123 Tailored-H Cervical Standalone System BCSD-3514 2026-09-30 00810204090130 Tailored-H Cervical Standalone System BCSD-3516 2026-09-30 00810204090147 Tailored-H Cervical Standalone System BCSD-3518 2026-09-30 00810204090154 Tailored-H Cervical Standalone System BCSD-4012 2026-09-30 00810204090161 Tailored-H Cervical Standalone System BCSD-4014 2026-09-30 00810204090178 Tailored-H Cervical Standalone System BCSD-4016 2026-09-30 00810204090185 Tailored-H Cervical Standalone System BCSD-4018 2026-09-30 00810204090192 Tailored-H Cervical Standalone System BCSL-001 2026-09-30 00810204090420 Tailored-C Cervical Interbody Fusion System BC7-1416-5 2026-09-30
Other Devices Sharing Product Codes#