FDA.reportPublic FDA data

ACURA Stabilization System

Primary DI
G832F00503550
Brand
ACURA Stabilization System
Company
Bioalign Inc.
Model
F005.0355
Catalog number
F005.0355
Device description
Cannulated Tap Dia.5.5mm
Published
2026-03-09
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
HWXTap, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G832F00503550PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
111818362
Device count
1
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G832A00420350ACURA Stabilization SystemA004.2035A004.20352026-03-09
G832A00420400ACURA Stabilization SystemA004.2040A004.20402026-03-09
G832A00420450ACURA Stabilization SystemA004.2045A004.20452026-03-09
G832A00420500ACURA Stabilization SystemA004.2050A004.20502026-03-09
G832A00420550ACURA Stabilization SystemA004.2055A004.20552026-03-09
G832A00420600ACURA Stabilization SystemA004.2060A004.20602026-03-09
G832A00420650ACURA Stabilization SystemA004.2065A004.20652026-03-09
G832A00420700ACURA Stabilization SystemA004.2070A004.20702026-03-09
G832A00420750ACURA Stabilization SystemA004.2075A004.20752026-03-09
G832A00420800ACURA Stabilization SystemA004.2080A004.20802026-03-09
G832A00420850ACURA Stabilization SystemA004.2085A004.20852026-03-09
G832A00420900ACURA Stabilization SystemA004.2090A004.20902026-03-09
G832A00420950ACURA Stabilization SystemA004.2095A004.20952026-03-09
G832A00440010ACURA Stabilization SystemA004.4001A004.40012026-03-09
G832A00471250ACURA Stabilization SystemA004.7125A004.71252026-03-09
G832A00471300ACURA Stabilization SystemA004.7130A004.71302026-03-09
G832A00471350ACURA Stabilization SystemA004.7135A004.71352026-03-09
G832A00471400ACURA Stabilization SystemA004.7140A004.71402026-03-09
G832A00471450ACURA Stabilization SystemA004.7145A004.71452026-03-09
G832A00472350ACURA Stabilization SystemA004.7235A004.72352026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120125220280Shark Screw® tapsurgebright GmbHHWX2026-04-30
10885862634351EquinoxeExactech, Inc.HWX2026-04-28
10705034577913N/AMedos International SàrlHWX2026-04-23
10705034577920N/AMedos International SàrlHWX2026-04-23
10705034577937N/AMedos International SàrlHWX2026-04-23
10705034577944N/AMedos International SàrlHWX2026-04-23
10705034577951N/AMedos International SàrlHWX2026-04-23
10705034577968N/AMedos International SàrlHWX2026-04-23
10705034577975N/AMedos International SàrlHWX2026-04-23
10705034577982N/AMedos International SàrlHWX2026-04-23
10705034577999N/AMedos International SàrlHWX2026-04-23
G079C5020000950Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
G079C5020001000Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
G079C5020001050Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
07640450868374PERLA ®SpineArt SAHWX2025-11-10
07640450868381PERLA ®SpineArt SAHWX2025-11-10
08800308480564INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480571INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480588INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480595INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480601INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
09120125220136Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220143Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220150Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220167Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220174Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220181Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220198Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220204Shark Screw® tapsurgebright GmbHHWX2025-09-16
07640177820464Neo Medical Pedicle Screw SystemNeo Medical SAHWX2023-01-25