ACURA Stabilization System A004.2065

GUDID G832A00420650

5.5 x 65 mm Rod Curved

Bioalign Inc.

Bone-screw internal spinal fixation system rod

• Primary Device ID: G832A00420650
• NIH Device Record Key: a4876c58-8cd4-4971-86b3-8eea264ad84f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACURA Stabilization System
• Version Model Number: A004.2065
• Catalog Number: A004.2065
• Company DUNS: 111818362
• Company Name: Bioalign Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(214)972-8683
• Email: admin@bioalignusa.com
• Phone: +1(214)972-8683
• Email: admin@bioalignusa.com
• Phone: +1(214)972-8683
• Email: admin@bioalignusa.com
• Phone: +1(214)972-8683
• Email: admin@bioalignusa.com
• Phone: +1(214)972-8683
• Email: admin@bioalignusa.com
• Phone: +1(214)972-8683
• Email: admin@bioalignusa.com
• Phone: +1(214)972-8683
• Email: admin@bioalignusa.com

Device Dimensions

• Outer Diameter: 5.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 65 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G832A00420650 [Primary]

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[G832A00420650]

Moist Heat or Steam Sterilization

[G832A00420650]

Moist Heat or Steam Sterilization

[G832A00420650]

Moist Heat or Steam Sterilization

[G832A00420650]

Moist Heat or Steam Sterilization

[G832A00420650]

Moist Heat or Steam Sterilization

[G832A00420650]

Moist Heat or Steam Sterilization

[G832A00420650]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-17
• Device Publish Date: 2026-03-09

On-Brand Devices [ACURA Stabilization System]

• G832F00503650: Cannulated Tap Dia.6.5mm
• G832F00503550: Cannulated Tap Dia.5.5mm
• G832F00503450: Cannulated Tap Dia.4.5mm
• G832F00503040: Rigid Driver, Long Tab Screw
• G832F005010308: Dilator-3
• G832F005010207: Dilator-2
• G832F005010106: Dilator-1
• G832F00500340: Rachet Driver
• G832F00500330: Screw Head Tubes
• G832F005003108: MIS Compressor
• G832F005003007: Guidewire (Threaded)
• G832F00500090: Rod Inserter Threaded Shaft
• G832F00500080: Rod Inserter Sleeve
• G832A00540000: Locking Cap Cannulated Screw
• G832A00531500: 5.5 x 150 mm TAV Straight Rod, Square End
• G832A00531300: 5.5 x 130 mm TAV Straight Rod, Square End
• G832A00531200: 5.5 x 120 mm TAV Straight Rod, Square End
• G832A00531100: 5.5 x 110 mm TAV Straight Rod, Square End
• G832A00531000: 5.5 x 100 mm TAV Straight Rod, Square End
• G832A00530900: 5.5 x 90 mm TAV Straight Rod, Square End
• G832A00520850: 5.5 x 85 mm TAV Curved Rod, Square End
• G832A00520800: 5.5 x 80 mm TAV Curved Rod, Square End
• G832A00520750: 5.5 x 75 mm TAV Curved Rod, Square End
• G832A00520700: 5.5 x 70 mm TAV Curved Rod, Square End
• G832A00520650: 5.5 x 65 mm TAV Curved Rod, Square End
• G832A00520600: 5.5 x 60 mm TAV Curved Rod, Square End
• G832A00520550: 5.5 x 55 mm TAV Curved Rod, Square End
• G832A00520500: 5.5 x 50 mm TAV Curved Rod, Square End
• G832A00520450: 5.5 x 45 mm TAV Curved Rod, Square End
• G832A00520400: 5.5 x 40 mm TAV Curved Rod, Square End
• G832A00514500: 7.5 x 50mm Cannulated Long Tab Polyaxial Screw
• G832A00514450: 7.5 x 45mm Cannulated Long Tab Polyaxial Screw
• G832A00514400: 7.5 x 40mm Cannulated Long Tab Polyaxial Screw
• G832A00514350: 7.5 x 35mm Cannulated Long Tab Polyaxial Screw
• G832A00513500: 6.5 x 50mm Cannulated Long Tab Polyaxial Screw
• G832A00513450: 6.5 x 45mm Cannulated Long Tab Polyaxial Screw
• G832A00513400: 6.5 x 40 mm Cannulated Long Tab Polyaxial Screw
• G832A00513350: 6.5 x 35 mm Cannulated Long Tab Polyaxial Screw
• G832A00512500: 5.5 x 50 mm Cannulated Long Tab Polyaxial Screw
• G832A00512450: 5.5 x 45 mm Cannulated Long Tab Polyaxial Screw
• G832A00512400: 5.5 x 40 mm Cannulated Long Tab Polyaxial Screw
• G832A00512350: 5.5x35mm Cannulated Long Tab Polyaxial Screw
• G832A00512300: 5.5x30mm Cannulated Long Tab Polyaxial Screw
• G832A00475550: Polyaxial Screw Assembly Ø 8.5 x 55 mm NT
• G832A00475350: Polyaxial Screw Assembly Ø 8.5 x 35 mm NT
• G832A00474600: Polyaxial Screw Assembly Ø 7.5 x 60 mm NT
• G832A00474550: Polyaxial Screw Assembly Ø 7.5 x 55 mm NT
• G832A00474500: Polyaxial Screw Assembly Ø 7.5 x 50 mm NT
• G832A00474450: Polyaxial Screw Assembly Ø 7.5 x 45 mm NT
• G832A00474400: Polyaxial Screw Assembly Ø 7.5 x 40 mm NT