Home GUDID M719GLL1150 3DP Lumbar Interbody System
Primary DI M719GLL1150
Brand 3DP Lumbar Interbody System
Company Genesys Orthopedics Systems LLC
Model 1
Catalog number GLL115
Device description LLIF Standard Straight Inserter
Published 2026-10-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false
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 M719GLL1150 Primary HIBCC 0
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 017921066 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 B648C29510000 Savant Lumbar Interbody Fusion System CURITEVA, INC. MAX 2026-10-19 M719GLL1140 3DP Lumbar Interbody System Genesys Orthopedics Systems LLC MAX 2026-10-19 M719GLL1160 3DP Lumbar Interbody System Genesys Orthopedics Systems LLC MAX 2026-10-19 00810161900381 EARP, 14X25X08 0° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900398 EARP, 14X25X10 6° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900404 EARP, 14X25X12 6° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900411 EARP, 14X25X12 12° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900428 EARP, 14X30X08 0° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900435 EARP, 14X30X10 6° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900442 EARP, 14X30X12 6° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900459 EARP, 14X30X12 12° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900466 EARP, 14X35X08 0° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900473 EARP, 14X35X10 6° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900480 EARP, 14X35X12 6° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900497 EARP, 14X35X12 12° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900503 EARP, 14X40X10 6° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900510 EARP, 14X40X12 6° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900527 EARP, 14X40X12 12° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900534 EARP, 18X30X08 0° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900541 EARP, 18X30X10 6° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900558 EARP, 18X30X12 6° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900565 EARP, 18X30X12 12° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900572 EARP, 18X35X08 0° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900589 EARP, 18X35X10 6° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900596 EARP, 18X35X12 6° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900602 EARP, 18X35X14 6° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900619 EARP, 18X35X12 12° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900626 EARP, 18X35X14 12° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900633 EARP, 18X40X10 6° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16 00810161900640 EARP, 18X40X12 6° RETROPSOAS TECHNOLOGIES, LLC MAX 2026-10-16