FDA.reportPublic FDA data

Aranax Anterior Cervical Plating System

Primary DI
M697T08603001
Brand
Aranax Anterior Cervical Plating System
Company
Xtant Medical Holdings, Inc.
Model
T086-0300
Device description
ADJUSTABLE GUIDE INSERT
Published
2015-12-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXYBRACE, DRILL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXYBrace, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697T08603000Direct MarkingHIBCC0
M697T08603001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(937)847-8400orders@x-spine.com

Regulatory Flags#

DUNS number
081224143
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840311263042Streamline TL Spinal Fixation System01-FX-55-5501-FX-55-552026-06-02
00840311263059Streamline TL Spinal Fixation System01-FX-55-6001-FX-55-602026-06-02
00840311263066Streamline TL Spinal Fixation System01-FX-65-6501-FX-65-652026-06-02
00840311263073Streamline TL Spinal Fixation System01-FX-65-7001-FX-65-702026-06-02
00840311263080Streamline TL Spinal Fixation System01-FX-65-7501-FX-65-752026-06-02
00840311263097Streamline TL Spinal Fixation System01-FX-65-8001-FX-65-802026-06-02
00840311263103Streamline TL Spinal Fixation System01-FX-65-8501-FX-65-852026-06-02
00840311263110Streamline TL Spinal Fixation System01-FX-65-9001-FX-65-902026-06-02
00840311263127Streamline TL Spinal Fixation System01-FX-65-9501-FX-65-952026-06-02
00840311263134Streamline TL Spinal Fixation System01-FX-65-10001-FX-65-1002026-06-02
00840311263141Streamline TL Spinal Fixation System01-FX-75-6501-FX-75-652026-06-02
00840311263158Streamline TL Spinal Fixation System01-FX-75-7001-FX-75-702026-06-02
00840311263165Streamline TL Spinal Fixation System01-FX-75-7501-FX-75-752026-06-02
00840311263172Streamline TL Spinal Fixation System01-FX-75-8001-FX-75-802026-06-02
00840311263189Streamline TL Spinal Fixation System01-FX-75-8501-FX-75-852026-06-02
00840311263196Streamline TL Spinal Fixation System01-FX-75-9001-FX-75-902026-06-02
00840311263202Streamline TL Spinal Fixation System01-FX-75-9501-FX-75-952026-06-02
00840311263219Streamline TL Spinal Fixation System01-FX-75-10001-FX-75-1002026-06-02
00840311263226Streamline TL Spinal Fixation System01-PA-115-7001-PA-115-702026-06-02
00840311263233Streamline TL Spinal Fixation System01-PA-115-8001-PA-115-802026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862605764EPICExactech, Inc.HXY2026-04-28
05055662970593ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-08-14
05055662971293Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971309Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971316Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971323Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
00889024682399PSN TM TIB DRILL GDEZimmer, Inc.HXY2025-01-13
00810027271594Citrelock ACL Tibial Drill Guide, Flat HookAcuitive Technologies, Inc.HXY2024-12-03
00191083044569Meniscus Allograft Transplantation (MAT)Rti Surgical, Inc.HXY2024-10-14
04049197096812RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-07-16
04049197096744RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-07-15
04026575534678LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGHXY2024-07-11
04026575534739LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGHXY2024-07-11
04049197187848RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-06-28
00840183516031BR Surgical, LLCBR Surgical, LLCHXY2024-06-03
00840183516048BR Surgical, LLCBR Surgical, LLCHXY2024-06-03
M73910290060TransFasten-LSF, Offset GuideCAPTIVA SPINE, INC.HXY2024-04-25
M73910290130TransFasten - LSF, Sharp Guide Pin Ø3.2mm x 229mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290140TransFasten - LSF, Blunt Guide Pin Ø3.2mm x 229mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290150TransFasten - LSF, Blunt Guide Pin Ø3.2mm x 457mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290170TransFasten - LSF, Open-Ended Offset GuideCAPTIVA SPINE, INC.HXY2024-04-25
M73910290180TransFasten - LSF, Parallel GuideCAPTIVA SPINE, INC.HXY2024-04-25
05055662969825COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969832COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969849COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969856COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969863COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969870COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
M7392030002104-Hole Drill GuideCAPTIVA SPINE, INC.HXY2024-03-11
08033860019105BIOPSYBELLBIOPSYBELL SRLHXY2024-02-23