FDA.reportPublic FDA data

Stasys-C Standalone

Primary DI
M719GAC302090
Brand
Stasys-C Standalone
Company
Genesys Orthopedics Systems LLC
Model
1
Catalog number
GAC302-09
Device description
Parallel Cervical Double Trial, 9mm
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
M719GAC302090PrimaryHIBCC0

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
Height9Millimeter

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
M719GLL11403DP Lumbar Interbody System1GLL1142026-10-19
M719GLL11503DP Lumbar Interbody System1GLL1152026-10-19
M719GLL11603DP Lumbar Interbody System1GLL1162026-10-19
M719GSIX1270Sacroiliac Joint Fusion System1GSI-X1272026-10-19
M719GSIX1210TiLock1GSI-X1212026-08-18
M719IST80030C0TiLock1IS-T80030-C2026-08-18
M719IST80035C0TiLock1IS-T80035-C2026-08-18
M719IST80040C0TiLock1IS-T80040-C2026-08-18
M719IST80045C0TiLock1IS-T80045-C2026-08-18
M719IST80050C0TiLock1IS-T80050-C2026-08-18
M719IST80055C0TiLock1IS-T80055-C2026-08-18
M719IST80060C0TiLock1IS-T80060-C2026-08-18
M719IST80065C0TiLock1IS-T80065-C2026-08-18
M719IST80070C0TiLock1IS-T80070-C2026-08-18
M719IST80075C0TiLock1IS-T80075-C2026-08-18
M719IST80080C0TiLock1IS-T80080-C2026-08-18
M719IST80085C0TiLock1IS-T80085-C2026-08-18
M719IST80090C0TiLock1IS-T80090-C2026-08-18
M719IST80095C0TiLock1IS-T80095-C2026-08-18
M719IST80100C0TiLock1IS-T80100-C2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810216329235ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329242ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329259ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329266ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329273ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329280ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329297ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329303ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329310ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329334ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329341ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329358ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329372ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329389ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329396ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329402ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329419ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
B084AC1141605070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141606070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141607070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141608070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141609070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141610070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141611070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141612070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161805000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161805040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161805070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161806000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161806040Anterior Cervical IBFDKEOSODP2024-02-09