FDA.reportPublic FDA data

Apache Anchored Cervical Interbody Fusion System

Primary DI
M719GCV10811L0
Brand
Apache Anchored Cervical Interbody Fusion System
Company
Genesys Orthopedics Systems LLC
Model
1
Catalog number
GCV108-11-L
Device description
Large 11mm Cervical Rasp
Published
2023-07-20
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
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
K152099000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152099000Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine2016-07-28OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M719GCV10811L0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height11Millimeter

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
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
M719IST80105C0TiLock1IS-T80105-C2026-08-18
M719IST80110C0TiLock1IS-T80110-C2026-08-18
M719IST80115C0TiLock1IS-T80115-C2026-08-18
M719IST80120C0TiLock1IS-T80120-C2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810216325442ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325466ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325800ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325817ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325824ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325831ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325848ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325855ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325862ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325879ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325886ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325893ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325909ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325916ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325923ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325930ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325947ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325954ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325961ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325978ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325985ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325992ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216326005ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216326012ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216326029ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216326036ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216326043ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216326050ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216326067ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216326074ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17