FDA.reportPublic FDA data

Stasys-C Standalone

Primary DI
M719GAC302120
Brand
Stasys-C Standalone
Company
Genesys Orthopedics Systems LLC
Model
1
Catalog number
GAC302-12
Device description
Parallel Cervical Double Trial, 12mm
Published
2026-04-01
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
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
K233594000
K242483000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233594000Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine2023-12-13OVE
K242483000Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine2025-02-07OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M719GAC302120PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height12Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
512-381-7070info@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
M719GL201TL0SIros-X1GL201T-L2026-07-23
M179GSI265STS0Sacroiliac Joint Fusion1GSI265-ST-S2026-07-14
M719G120140SIros-X12026-07-14
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
M719GCL09L0Apache1GCL-09-L2015-08-31
M719GCL09S0Apache1GCL-09-S2015-08-31
M719GCL10L0Apache1GCL-10-L2015-08-31
M719GCL10S0Apache1GCL-10-S2015-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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.OVE2026-07-23
00810017914579Saber-C Body (PT), 14x17x9 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
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
00843511102142Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102159Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102166Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102173Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102180Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102197Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102203Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102210Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102234Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102241Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102258Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102265Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102272Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22