Home GUDID 08800015912389 Maxima™ ACP System
Primary DI 08800015912389
Brand Maxima™ ACP System
Company CG MedTech Co.,Ltd.
Model SC4020-F
Published 2016-11-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name KWQ APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800015912389 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800015912389 08800015912389 8800015912389
GMDN Terms# Term, Definition table Term Definition Intervertebral-body internal spinal fixation system A group of sterile implantable devices designed to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The system components are typically made of medical grade titanium and consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the centre of each plate, and a braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and is fastened or crimped at each eye-type screw.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a cool dry place.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 688811082 Device count 1 DM exempt true Lot or batch true Serial number true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810017915125 SABER-XA, Screw Ø5.0 x 22.5 ELEVATION SPINE, INC. KWQ 2026-09-22 00810017915149 SABER-XA, Screw Ø5.0 x 32.5 ELEVATION SPINE, INC. KWQ 2026-09-22 00810017915156 SABER-XA, Screw Ø5.5 x 22.5 ELEVATION SPINE, INC. KWQ 2026-09-22 00810017915163 SABER-XA, Screw Ø5.5 x 27.5 ELEVATION SPINE, INC. KWQ 2026-09-22 00810017915170 SABER-XA, Screw Ø5.5 x 32.5 ELEVATION SPINE, INC. KWQ 2026-09-22 10888857598164 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598171 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598188 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598195 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598201 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598218 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598225 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598232 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598249 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 00810056993146 corra Carlsmed, Inc. KWQ 2026-01-30 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWQ 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWQ 2015-08-05 04546540147257 XIA II Stryker Corporation KWQ 2014-12-08 04546540147769 XIA II Stryker Corporation KWQ 2014-12-08 04546540147806 XIA II Stryker Corporation KWQ 2014-12-08 04546540147905 XIA II Stryker Corporation KWQ 2014-12-08 04546540147912 XIA I Stryker Corporation KWQ 2014-12-08 04546540147929 XIA I Stryker Corporation KWQ 2014-12-08 04546540147936 XIA I Stryker Corporation KWQ 2014-12-08 04546540147974 XIA I Stryker Corporation KWQ 2014-12-08 04546540147981 XIA I Stryker Corporation KWQ 2014-12-08 04546540147998 XIA I Stryker Corporation KWQ 2014-12-08 04546540148001 XIA II Stryker Corporation KWQ 2014-12-08 04546540148018 XIA II Stryker Corporation KWQ 2014-12-08 04546540148025 XIA II Stryker Corporation KWQ 2014-12-08