Home GUDID 00190376588520 AMP II
Primary DI 00190376588520
Brand AMP II
Company ALPHATEC SPINE, INC.
Model 614-111
Device description AMP II In-Situ Inserter, C/C
Published 2025-03-20
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 00190376588520 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 00190376588520 00190376588520 190376588520 0190376588520
GMDN Terms# Term, Definition table Term Definition Orthopaedic inorganic implant inserter/extractor, reusable A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.
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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