Home GUDID 00190376635453 AMP II
Primary DI 00190376635453
Brand AMP II
Company ALPHATEC SPINE, INC.
Model 616-1-04
Device description AMP II Plate and Center Screw, 1-Hole, 04
Published 2025-03-20
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 OVD Intervertebral fusion device with integrated fixation, lumbar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190376635453 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 00190376635453 00190376635453 190376635453 0190376635453
GMDN Terms# Term, Definition table Term Definition Spinal fixation plate, non-bioabsorbable A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 602465783 Device count 1 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 00840606187565 Ventana A SPINAL ELEMENTS, INC. OVD 2026-09-25 00840606187572 Ventana A SPINAL ELEMENTS, INC. OVD 2026-09-25 00840606187589 Ventana A SPINAL ELEMENTS, INC. OVD 2026-09-25 00840606187596 Ventana A SPINAL ELEMENTS, INC. OVD 2026-09-25 00840606187602 Ventana A SPINAL ELEMENTS, INC. OVD 2026-09-25 00840606187619 Ventana A SPINAL ELEMENTS, INC. OVD 2026-09-25 00840606187633 Ventana A SPINAL ELEMENTS, INC. OVD 2026-09-25 00810017915170 SABER-XA, Screw Ø5.5 x 32.5 ELEVATION SPINE, INC. OVD 2026-09-22 10888857461819 CASCADIA™ Interbody System VB Spine LLC OVD 2019-10-31 10888857461888 CASCADIA™ Interbody System VB Spine LLC OVD 2019-10-31 10888857218772 CASCADIA™ Interbody System VB Spine LLC OVD 2015-12-16 10888857218963 CASCADIA™ Interbody System VB Spine LLC OVD 2015-12-16 10888857219076 CASCADIA™ Interbody System VB Spine LLC OVD 2015-12-16 10888857219489 CASCADIA™ Interbody System VB Spine LLC OVD 2015-12-16 10888857219595 CASCADIA™ Interbody System VB Spine LLC OVD 2015-12-16 07613153046196 AVS PL Stryker Corporation OVD 2015-09-14 07613153046202 AVS PL Stryker Corporation OVD 2015-09-14 07613153046219 AVS PL Stryker Corporation OVD 2015-09-14 07613153046226 AVS PL Stryker Corporation OVD 2015-09-14 07613153046233 AVS PL Stryker Corporation OVD 2015-09-14 07613153046288 AVS PL Stryker Corporation OVD 2015-09-14 07613153046295 AVS PL Stryker Corporation OVD 2015-09-14 07613153046301 AVS PL Stryker Corporation OVD 2015-09-14 07613153046318 AVS PL Stryker Corporation OVD 2015-09-14 07613153046325 AVS PL Stryker Corporation OVD 2015-09-14 07613153046332 AVS PL Stryker Corporation OVD 2015-09-14 07613153046349 AVS PL Stryker Corporation OVD 2015-09-14 07613153046356 AVS PL Stryker Corporation OVD 2015-09-14 07613153046363 AVS PL Stryker Corporation OVD 2015-09-14 07613153046370 AVS PL Stryker Corporation OVD 2015-09-14
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