Home GUDID 00190376467887 Calibrate
Primary DI 00190376467887
Brand Calibrate
Company ALPHATEC SPINE, INC.
Model 322-100
Device description PSX Lordotic Expandable, Inserter
Published 2022-11-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name MAX Intervertebral fusion device with bone graft, lumbar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190376467887 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 00190376467887 00190376467887 190376467887 0190376467887
GMDN Terms# Term, Definition table Term Definition Orthopaedic implant inserter/extractor, reusable A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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 00840606185110 LUNA Ti SPINAL ELEMENTS, INC. MAX 2026-09-25 00840606185127 LUNA Ti SPINAL ELEMENTS, INC. MAX 2026-09-25 00840606185134 LUNA Ti SPINAL ELEMENTS, INC. MAX 2026-09-25 00840606185141 LUNA Ti SPINAL ELEMENTS, INC. MAX 2026-09-25 00840606185158 LUNA Ti SPINAL ELEMENTS, INC. MAX 2026-09-25 00840606185165 LUNA Ti SPINAL ELEMENTS, INC. MAX 2026-09-25 00840606196024 Vertu SPINAL ELEMENTS, INC. MAX 2026-09-25 00840606196031 Vertu SPINAL ELEMENTS, INC. MAX 2026-09-25 00840606196048 Vertu SPINAL ELEMENTS, INC. MAX 2026-09-25 00810017915170 SABER-XA, Screw Ø5.5 x 32.5 ELEVATION SPINE, INC. MAX 2026-09-22 10888857461819 CASCADIA™ Interbody System VB Spine LLC MAX 2019-10-31 10888857461888 CASCADIA™ Interbody System VB Spine LLC MAX 2019-10-31 04546540665720 AVS NAVIGATOR Stryker Corporation MAX 2016-09-24 10888857218772 CASCADIA™ Interbody System VB Spine LLC MAX 2015-12-16 10888857218963 CASCADIA™ Interbody System VB Spine LLC MAX 2015-12-16 10888857219076 CASCADIA™ Interbody System VB Spine LLC MAX 2015-12-16 10888857219489 CASCADIA™ Interbody System VB Spine LLC MAX 2015-12-16 10888857219595 CASCADIA™ Interbody System VB Spine LLC MAX 2015-12-16 07613153046196 AVS PL Stryker Corporation MAX 2015-09-14 07613153046202 AVS PL Stryker Corporation MAX 2015-09-14 07613153046219 AVS PL Stryker Corporation MAX 2015-09-14 07613153046226 AVS PL Stryker Corporation MAX 2015-09-14 07613153046233 AVS PL Stryker Corporation MAX 2015-09-14 07613153046288 AVS PL Stryker Corporation MAX 2015-09-14 07613153046295 AVS PL Stryker Corporation MAX 2015-09-14 07613153046301 AVS PL Stryker Corporation MAX 2015-09-14 07613153046318 AVS PL Stryker Corporation MAX 2015-09-14 07613153046325 AVS PL Stryker Corporation MAX 2015-09-14 07613153046332 AVS PL Stryker Corporation MAX 2015-09-14 07613153046349 AVS PL Stryker Corporation MAX 2015-09-14
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