FDA.reportPublic FDA data

ACURA Stabilization System

Primary DI
G832F00500330
Brand
ACURA Stabilization System
Company
Bioalign Inc.
Model
F005.0033
Catalog number
F005.0033
Device description
Screw Head Tubes
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G832F00500330PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. 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
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03