Home GUDID 08800037560056 OPTIMA™ Spinal System
Primary DI 08800037560056
Brand OPTIMA™ Spinal System
Company CG MedTech Co.,Ltd.
Model SM7135
Published 2023-02-25
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 08800037560056 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800037560056 08800037560056 8800037560056
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
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