FDA.reportPublic FDA data

ACURA Stabilization System

Primary DI
B922A00471250
Brand
ACURA Stabilization System
Company
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
Model
A004.7125
Catalog number
A004.7125
Device description
ACURA Stabilization System Ø 4.5 x 25 mm Polyaxial Screw - NT
Published
2026-02-04
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
KWPAppliance, Fixation, Spinal Interlaminal
KWQAppliance, Fixation, Spinal Intervertebral Body
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B922A00471250PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Millimeter
Outer Diameter4.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(214)972-8683info@indiusmedical.com

Regulatory Flags#

DUNS number
860396609
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B922F004800208ACURA Stabilization SystemF004.8002F004.80022026-03-11
B922F005001505Acura Stabilization SystemF005.0015F005.00152026-03-11
B922F005001707ACURA Stabilization SystemF005.0017F005.00172026-03-11
B922F005001808ACURA Stabilization SystemF005.0018F005.00182026-03-11
B922F005003608ACURA Stabilization SystemF005.0036F005.00362026-03-11
B922F005003709ACURA Stabilization SystemF005.0037F005.00372026-03-11
B922F00500380ACURA Stabilization SystemF005.0038F005.00382026-03-11
B922F00500390ACURA Stabilization SystemF005.0039F005.00392026-03-11
B922IMDT00490ACURA Stabilization System IMDT.0049IMDT.00492026-03-11
B922F005000100Guidewire ( Non-Threaded)F005.0001F005.00012026-03-09
B922F005000201Access Needle (8 Gauge)F005.0002F005.00022026-03-09
B922F005000706Rod CaliperF005.0007F005.00072026-03-09
B922A00470200ACURA Stabilization SystemA004.7020A004.70202026-02-04
B922A00470250ACURA Stabilization SystemA004.7025A004.70252026-02-04
B922A00470300ACURA Stabilization SystemA004.7030A004.70302026-02-04
B922A00470350ACURA Stabilization SystemA004.7035A004.70352026-02-04
B922A00470400ACURA Stabilization SystemA004.7040A004.70402026-02-04
B922A00470450ACURA Stabilization SystemA004.7045A004.70452026-02-04
B922A0047130ACURA Stabilization SystemA004.7130A004.71302026-02-04
B922A00472600ACURA Stabilization System A004.7260A004.72602026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000859404CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-18
00763000859404CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-18
00763000859404CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-18
00763000910365CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-18
00763000910365CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-18
00763000910365CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-18
20763000910376CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-18
20763000910376CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-18
20763000910376CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-18
18257200054206SFSOrthofix US LLCNKB2026-07-17
18257200054213SFSOrthofix US LLCNKB2026-07-17
18257200054220SFSOrthofix US LLCNKB2026-07-17
18257200054237SFSOrthofix US LLCNKB2026-07-17
18257200054244SFSOrthofix US LLCNKB2026-07-17
18257200054251SFSOrthofix US LLCNKB2026-07-17
18257200054268SFSOrthofix US LLCNKB2026-07-17
18257200054275SFSOrthofix US LLCNKB2026-07-17
18257200054282SFSOrthofix US LLCNKB2026-07-17
18257200054299SFSOrthofix US LLCNKB2026-07-17
18257200054305SFSOrthofix US LLCNKB2026-07-17
18257200054312SFSOrthofix US LLCNKB2026-07-17
00199150015832INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015849INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015856INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015863INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015870INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015887INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015894INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015900INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015917INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16