FDA.reportPublic FDA data

Stasys-C Standalone 3DP

Primary DI
M719ACC840XL0
Brand
Stasys-C Standalone 3DP
Company
Genesys Orthopedics Systems LLC
Model
1
Catalog number
ACC840-XL
Device description
Stasys Cervical-SA Anchor - TI, Extra Large
Published
2025-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233594000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M719ACC840XL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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
10195860030421E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030438E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030445E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030452E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030506E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030537E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030551E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030568E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030575E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030582E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030599E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030605E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030612E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030674E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030704E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030728E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030742E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030766E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030780E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030803E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030810E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030827E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030834E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030841E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030858E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030889E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030896E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030919E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030926E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030964E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20