Home GUDID 00840967193656 Core Lumbar Fixation System
Primary DI 00840967193656
Brand Core Lumbar Fixation System
Company ALPHATEC SPINE, INC.
Model 81100-45
Device description 6.35mm ADJUSTABLE BRIDGE, 37mm - 45mm
Published 2020-07-23
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 KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL MNH Orthosis, spondylolisthesis spinal fixation MNI Orthosis, spinal pedicle fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2 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 00840967193656 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 00840967193656 00840967193656 840967193656 0840967193656
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 602465783 Device count 1 DM exempt true Lot or batch 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 00840606186544 OMEGA XP SPINAL ELEMENTS, INC. KWP 2026-09-22 00840606186551 OMEGA XP SPINAL ELEMENTS, INC. KWP 2026-09-22 00613994738646 ZEPHIR® Anterior Cervical System MEDTRONIC SOFAMOR DANEK, INC. KWP 2019-03-07 00613994887955 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-09-17 00613994887955 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-09-17 00613994887955 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-09-17 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 04546540147257 XIA II Stryker Corporation MNH 2014-12-08 04546540147257 XIA II Stryker Corporation MNI 2014-12-08 04546540147257 XIA II Stryker Corporation KWP 2014-12-08 04546540147769 XIA II Stryker Corporation KWP 2014-12-08 04546540147769 XIA II Stryker Corporation MNH 2014-12-08 04546540147769 XIA II Stryker Corporation MNI 2014-12-08 04546540147806 XIA II Stryker Corporation MNI 2014-12-08 04546540147806 XIA II Stryker Corporation KWP 2014-12-08 04546540147806 XIA II Stryker Corporation MNH 2014-12-08 04546540147905 XIA II Stryker Corporation MNH 2014-12-08 04546540147905 XIA II Stryker Corporation KWP 2014-12-08 04546540147905 XIA II Stryker Corporation MNI 2014-12-08
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