FDA.reportPublic FDA data

Apache

Primary DI
M719GCV70811L0
Brand
Apache
Company
Genesys Orthopedics Systems LLC
Model
1
Catalog number
GCV108-11-L
Device description
Apache Anchored Cervical Rasp - 11mm, Large
Published
2016-09-30
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
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M719GCV70811L0PrimaryHIBCC0

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
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
M719GCL11L0Apache1GCL-11-L2015-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776391720CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391737CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391744CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391751CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391768CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391775CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391782CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391799CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391805CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391812CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391829CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391836CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391843CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391850CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391867CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391874CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
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00190776391898CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
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00190776391928CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
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00190776391959CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
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00190776391973CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391980CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391997CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776392000CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776392017CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11