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
B382SD1455810020Surgical DirectSurgical Direct, Inc.HXX2026-09-29
B382SD1455810030Surgical DirectSurgical Direct, Inc.HXX2026-09-29
10886982345462VOLTSynthes GmbHHXX2026-09-25
00840606197342OmegaSPINAL ELEMENTS, INC.HXX2026-09-22
07640139343185BAGUERA C INSTRUMENTATIONSpineArt SAHXX2026-08-27
00843210143644Monaco Pedicle Screw SystemAltus Spine, LLCHXX2026-08-24
00199150083091Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-22
B095329646Hintermann SeriesDt Medtech, LLCHXX2026-08-21
00199150083459Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-08
00199150083466Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-08
00199150076468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-03
00199150076475Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-03
00840606191616Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191623Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191746Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191753Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191784Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191944Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191951Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191982Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
03701089540643AMPLITUDEAMPLITUDE SASHXX2026-07-29
03701089541022AMPLITUDEAMPLITUDE SASHXX2026-07-29
03700569670269Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569674649Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569679859Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569680282Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569680299Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
00824846003199Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
00824846003205Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
10887587078557NASynthes GmbHHXX2026-07-24