ACURA Stabilization System 8.5 mm x 45 mm Polyaxial Screw A004.0545

GUDID B922A00405450

ACURA Stabilization System 8.5 mm x 45 mm Polyaxial Screw

INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: B922A00405450
• NIH Device Record Key: ffc55348-9543-4a10-83f2-c31caf0daaa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACURA Stabilization System 8.5 mm x 45 mm Polyaxial Screw
• Version Model Number: A004.0545
• Catalog Number: A004.0545
• Company DUNS: 860396609
• Company Name: INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
• 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: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com
• Phone: +1214-972-8683
• Email: info@indiusmedical.com

Device Dimensions

• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B922A00405450 [Primary]

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

[B922A00405450]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-19
• Device Publish Date: 2022-10-11

Devices Manufactured by INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

• B922F008000103 - Cervical Awl: 2024-10-25 Cervical Awl
• B922A00471300 - ACURA Stabilization System Ø 4.5 x 30 mm Polyaxial Screw - NT: 2024-04-10 ACURA Stabilization System Ø 4.5 x 30 mm Polyaxial Screw - NT
• B922F00400780 - Screw Head Positioner: 2024-04-09 Screw Head Positioner
• B922F00403270 - ACURA Stabilization System - Rigid Screw Driver,SNAP ON (NT): 2024-04-05 Rigid Screw Driver, SNAP ON (NT)
• B922A00471350 - ACURA Stabilization System Ø 4.5 x 35 mm Polyaxial Screw - NT: 2024-03-26 ACURA Stabilization System Ø 4.5 x 35 mm Polyaxial Screw - NT
• B922A00471400 - ACURA Stabilization System Ø 4.5 x 40 mm Polyaxial Screw - NT: 2024-03-26 ACURA Stabilization System Ø 4.5 x 40 mm Polyaxial Screw - NT
• B922A00471450 - ACURA Stabilization System Ø 4.5 x 45 mm Polyaxial Screw - NT: 2024-03-26 ACURA Stabilization System Ø 4.5 x 45 mm Polyaxial Screw - NT
• B922F00300210 - Alignment Jig: 2023-11-09 Alignment Jig