Home GUDID 08800037581600 ANAX™ 5.5 SPINAL SYSTEM
Primary DI 08800037581600
Brand ANAX™ 5.5 SPINAL SYSTEM
Company CG MedTech Co.,Ltd.
Model SFA6530
Published 2023-09-15
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 MNH Orthosis, spondylolisthesis spinal fixation MNI Orthosis, spinal pedicle fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2 MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800037581600 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800037581600 08800037581600 8800037581600
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 Manufacturing date on label 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 B678520297S0 PressON™ NEXUS SPINE, L.L.C. MNI 2026-07-10 B678520297S0 PressON™ NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520298S0 PressON™ NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520298S0 PressON™ NEXUS SPINE, L.L.C. MNI 2026-07-10 B678520299S0 PressON NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520299S0 PressON NEXUS SPINE, L.L.C. MNI 2026-07-10 B678520300S0 PressON™ NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520300S0 PressON™ NEXUS SPINE, L.L.C. MNI 2026-07-10 B678520301S0 PressON NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520301S0 PressON NEXUS SPINE, L.L.C. MNI 2026-07-10 B678520302S0 PressON™ NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520302S0 PressON™ NEXUS SPINE, L.L.C. MNI 2026-07-10 B678520303S0 PressON NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520303S0 PressON NEXUS SPINE, L.L.C. MNI 2026-07-10 B678520304S0 PressON™ NEXUS SPINE, L.L.C. MNI 2026-07-10 B678520304S0 PressON™ NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520305S0 PressON NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520305S0 PressON NEXUS SPINE, L.L.C. MNI 2026-07-10 B678520306S0 PressON™ NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520306S0 PressON™ NEXUS SPINE, L.L.C. MNI 2026-07-10 00643169465879 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2026-06-28 00643169465879 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2026-06-28 10889981005115 Newport Seaspine Orthopedics Corporation MNH 2015-09-24 10889981005115 Newport Seaspine Orthopedics Corporation MNI 2015-09-24 10889981005139 Newport Seaspine Orthopedics Corporation MNI 2015-09-24 10889981005139 Newport Seaspine Orthopedics Corporation MNH 2015-09-24 10889981005146 Newport Seaspine Orthopedics Corporation MNI 2015-09-24 10889981005146 Newport Seaspine Orthopedics Corporation MNH 2015-09-24 10889981005290 Newport Seaspine Orthopedics Corporation MNI 2015-09-24 10889981005290 Newport Seaspine Orthopedics Corporation MNH 2015-09-24