FDA.reportPublic FDA data

ACURA Stabilization System

Primary DI
G832F00500340
Brand
ACURA Stabilization System
Company
Bioalign Inc.
Model
F005.0034
Catalog number
F005.0034
Device description
Rachet Driver
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
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G832F00500340PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

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
07640221373076PERLA ® TLSpineArt SAHXX2026-05-07
09120125220259Shark Screw® driver aclsurgebright GmbHHXX2026-04-30
08806373894213LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373899720LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373887789BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
08806373892660BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
07640332475294PERLA ®SpineArt SAHXX2025-11-10
07640332475300PERLA ®SpineArt SAHXX2025-11-10
07640332475317PERLA ®SpineArt SAHXX2025-11-10
08059386744253Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-06
08059386742266Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-05
09348215164737Turbine X Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164744Turbine X Driver – RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164751MI (Mini Incision) Driver - RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164768MI (Mini Incision) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164775O (Turbine OP) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151650172.9 Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165024Vector Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151651235.5 Knotless DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165130Screw DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165178Simple Driver (Black)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165185Simple Driver (Orange)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165208Tendonesis Chamfer ReamerSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165284Staple ShaftSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
G791CDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
G791SDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
09120125220037Shark Screw® couplingsurgebright GmbHHXX2025-09-16
09120125220228Shark Screw® driversurgebright GmbHHXX2025-09-16
08800071006848Surgical InstrumentOSTEONIC CO.,Ltd.HXX2025-06-24
08800071024248SignexOSTEONIC CO.,Ltd.HXX2025-06-24