FDA.reportPublic FDA data

3DP Lumbar Interbody System

Primary DI
M719GP0616LS0
Brand
3DP Lumbar Interbody System
Company
Genesys Orthopedics Systems LLC
Model
1
Catalog number
GP0616LS
Device description
16mm x 6 degree Large ALIF Stick Trial
Published
2025-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182987000Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine2019-12-12MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M719GP0616LS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5123817070info@genesysspine.com

Regulatory Flags#

DUNS number
017921066
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M719GAC301050Stasys-C Standalone1GAC301-052026-04-01
M719GAC301060Stasys-C Standalone1GAC301-062026-04-01
M719GAC301070Stasys-C Standalone1GAC301-072026-04-01
M719GAC301080Stasys-C Standalone1GAC301-082026-04-01
M719GAC301090Stasys-C Standalone1GAC301-092026-04-01
M719GAC301100Stasys-C Standalone1GAC301-102026-04-01
M719GAC301110Stasys-C Standalone1GAC301-112026-04-01
M719GAC301120Stasys-C Standalone1GAC301-122026-04-01
M719GAC302050Stasys-C Standalone1GAC302-052026-04-01
M719GAC302060Stasys-C Standalone1GAC302-062026-04-01
M719GAC302070Stasys-C Standalone1GAC302-072026-04-01
M719GAC302080Stasys-C Standalone1GAC302-082026-04-01
M719GAC302090Stasys-C Standalone1GAC302-092026-04-01
M719GAC302100Stasys-C Standalone1GAC302-102026-04-01
M719GAC302110Stasys-C Standalone1GAC302-112026-04-01
M719GAC302120Stasys-C Standalone1GAC302-122026-04-01
M719GAC303060Stasys-C Standalone1GAC303-062026-04-01
M719GAC303070Stasys-C Standalone1GAC303-072026-04-01
M719GAC303080Stasys-C Standalone1GAC303-082026-04-01
M719GAC303090Stasys-C Standalone1GAC303-092026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157075859ZAVATION INSERTERZavation LLCMAX2026-05-27
00810166522366X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
00810166522373X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
B70712535005S0Dual X Graft Tamp ShortAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010130DUALXS T/PLIF 15 DEG x 9-12MMAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010200DUALXS T/PLIF 18 DEG x 10-13MMAMPLIFY SURGICAL, INC.MAX2026-05-27
07613153046196AVS PLStryker CorporationMAX2015-09-14
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07613153046219AVS PLStryker CorporationMAX2015-09-14
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07613153046509AVS TLStryker CorporationMAX2015-09-14
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