FDA.reportPublic FDA data

3DP Cervical Interbody System

Primary DI
M719GC3100S0
Brand
3DP Cervical Interbody System
Company
Genesys Orthopedics Systems LLC
Model
1
Catalog number
GC3-100-S
Device description
3DP Cervical Interbody Inserter, Stop
Published
2021-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191489000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191489000Genesys Spine 3DP Cervical Interbody SystemGenesys Spine2020-01-08OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M719GC3100S0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manualA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M719G120140SIros-X1G120142026-07-14
M719G45120Apache1G45122018-12-14
M719GAC1020Apache1GAC1022018-12-14
M719G45150Apache AIS-C Standalone1G45152023-07-24
M719G45160Apache AIS-C Standalone1G45162023-07-24
M719GL201TL0SIros-X1GL201T-L2026-07-23
M179GSI265STS0Sacroiliac Joint Fusion1GSI265-ST-S2026-07-14
M719GGSI265XLGS0Sacroiliac Joint Fusion1GSI265-XLG-S2026-07-14
M719GL2290TiLock1GL2292026-07-14
M719GLL100QC03DP Lumbar Interbody System1GLL100-QC2026-07-14
M719GLL101QC03DP Lumbar Interbody System1GLL101-QC2026-07-14
M719GLL106QC03DP Lumbar Interbody System1GLL106-QC2026-07-14
M719GLL107QC03DP Lumbar Interbody System1GLL107-QC2026-07-14
M719GCL05L0Apache1GCL-05-L2015-08-31
M719GCL06L0Apache1GCL-06-L2015-08-31
M719GCL06S0Apache1GCL-06-S2015-08-31
M719GCL07L0Apache1GCL-07-L2015-08-31
M719GCL07S0Apache1GCL-07-S2015-08-31
M719GCL08L0Apache1GCL-08-L2015-08-31
M719GCL08S0Apache1GCL-08-S2015-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889929072929HONOUR® Spacer SystemNEXXT SPINE, LLCODP2026-07-29
00889929072936HONOUR® Spacer SystemNEXXT SPINE, LLCODP2026-07-29
B064XMPHC1640202Ø4.0mm X 20mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
B064XMPHC1640202Ø4.0mm X 20mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCODP2026-07-28
B064XMPHC1640222Ø4.0mm X 22mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
B064XMPHC1640222Ø4.0mm X 22mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCODP2026-07-28
B064XMPHC1640242Ø4.0mm X 24mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
B064XMPHC1640242Ø4.0mm X 24mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCODP2026-07-28
B064XMPHC1645202Ø4.5mm X 20mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
B064XMPHC1645202Ø4.5mm X 20mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCODP2026-07-28
B064XMPHC1645222Ø4.5mm X 22mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
B064XMPHC1645222Ø4.5mm X 22mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCODP2026-07-28
B064XMPHC1645242Ø4.5mm X 24mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCODP2026-07-28
B064XMPHC1645242Ø4.5mm X 24mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
G079100120705S1Advantage C Cervical Interbody Fusion DeviceIntelivation, LLCODP2026-07-24
G079100140705S1Advantage C Cervical Interbody Fusion DeviceIntelivation, LLCODP2026-07-24
00810017914548Saber-C Body (PT), 14x17x6 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914548Saber-C Body (PT), 14x17x6 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914555Saber-C Body (PT), 14x17x8 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914555Saber-C Body (PT), 14x17x8 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914562Saber-C Body (PT), 14x17x7 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914562Saber-C Body (PT), 14x17x7 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914579Saber-C Body (PT), 14x17x9 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914579Saber-C Body (PT), 14x17x9 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914647Saber-C Plate, 14x17x10 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914647Saber-C Plate, 14x17x10 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00843511102579Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-07-23
00843511102135Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22