Arx 148-353

GUDID 00190837035778

Lumbar Rod Bender

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837035778
• NIH Device Record Key: 28c6f85d-e5ed-4ede-b23b-a1dc83da518d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arx
• Version Model Number: 148-353
• Catalog Number: 148-353
• Company DUNS: 183641617
• Company Name: Life Spine, 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837035778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061600

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00190837035778]

Moist Heat or Steam Sterilization

[00190837035778]

Moist Heat or Steam Sterilization

[00190837035778]

Moist Heat or Steam Sterilization

[00190837035778]

Moist Heat or Steam Sterilization

[00190837035778]

Moist Heat or Steam Sterilization

[00190837035778]

Moist Heat or Steam Sterilization

[00190837035778]

Moist Heat or Steam Sterilization

[00190837035778]

Moist Heat or Steam Sterilization

[00190837035778]

Moist Heat or Steam Sterilization

[00190837035778]

Moist Heat or Steam Sterilization

[00190837035778]

Moist Heat or Steam Sterilization

[00190837035778]

Moist Heat or Steam Sterilization

[00190837035778]

Moist Heat or Steam Sterilization

[00190837035778]

Moist Heat or Steam Sterilization

[00190837035778]

Moist Heat or Steam Sterilization

[00190837035778]

Moist Heat or Steam Sterilization

[00190837035778]

Moist Heat or Steam Sterilization

[00190837035778]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-14
• Device Publish Date: 2019-11-06

On-Brand Devices [Arx]

• 00190837075514: Polyaxial Non-Cannulated Screw, 10.5x30mm
• 00190837075507: Polyaxial Non-Cannulated Screw, 10.5x 25mm
• 00190837075453: Polyaxial Non-Cannulated Screw, 10.5x55mm
• 00190837075446: Polyaxial Non-Cannulated Screw, 10.5x50mm
• 00190837075439: Polyaxial Non-Cannulated Screw, 10.5x45mm
• 00190837075422: Polyaxial Non-Cannulated Screw, 10.5x40mm
• 00190837075415: Polyaxial Non-Cannulated Screw, 10.5x35mm
• 00190837075200: Polyaxial Cannulated Screw 10.5x120mm
• 00190837075194: Polyaxial Cannulated Screw 10.5x110mm
• 00190837075057: Polyaxial Cannulated Screw (Closed) 9.5x120mm
• 00190837075040: Polyaxial Cannulated Screw (Closed) 9.5x110mm
• 00190837075033: Polyaxial Cannulated Screw (Closed) 9.5x100mm
• 00190837075026: Polyaxial Cannulated Screw (Closed) 9.5x90mm
• 00190837075019: Polyaxial Cannulated Screw (Closed) 9.5x80mm
• 00190837075002: Polyaxial Cannulated Screw (Closed) 9.5x70mm
• 00190837074999: Polyaxial Cannulated Screw 9.5x60mm
• 00190837074968: Polyaxial Cannulated Screw (Closed) 8.5x100mm
• 00190837074951: Polyaxial Cannulated Screw (Closed) 8.5x80mm
• 00190837074920: Polyaxial Cannulated Screw 8.5x60mm
• 00190837074845: Polyaxial Cannulated Screw 10.5x100mm
• 00190837074838: Polyaxial Cannulated Screw 10.5x90mm
• 00190837074821: Polyaxial Cannulated Screw 10.5x80mm
• 00190837074814: Polyaxial Cannulated Screw 10.5x70mm
• 00190837074807: Polyaxial Cannulated Screw 10.5x60mm
• 00190837074265: Closed Tulip Lock Screw
• 00190837074258: Polyaxial Non-Cannulated Screw (Closed) 9.5x90mm
• 00190837074241: Polyaxial Non-Cannulated Screw (Closed) 9.5x80mm
• 00190837074234: Polyaxial Non-Cannulated Screw (Closed) 9.5x70mm
• 00190837074227: Polyaxial Non-Cannulated Screw (Closed) 9.5x60mm
• 00190837074210: Polyaxial Non-Cannulated Screw (Closed) 9.5x120mm
• 00190837074203: Polyaxial Non-Cannulated Screw (Closed) 9.5x110mm
• 00190837074197: Polyaxial Non-Cannulated Screw (Closed) 9.5x100mm
• 00190837074173: Polyaxial Non-Cannulated Screw (Closed) 8.5x80mm
• 00190837074166: Polyaxial Non-Cannulated Screw (Closed) 8.5x70mm
• 00190837074135: Polyaxial Non-Cannulated Screw (Closed) 8.5x110mm
• 00190837074128: Polyaxial Non-Cannulated Screw (Closed) 8.5x100mm
• 00190837074111: Polyaxial Non-Cannulated Screw (Closed) 7.5x90mm
• 00190837073893: Polyaxial Non-Cannulated Screw, 10.5x90mm
• 00190837073886: Polyaxial Non-Cannulated Screw, 10.5x80mm
• 00190837073879: Polyaxial Non-Cannulated Screw, 10.5x70mm
• 00190837073862: Polyaxial Non-Cannulated Screw, 10.5x60mm
• 00190837073855: Polyaxial Non-Cannulated Screw 10.5x120mm
• 00190837073848: Polyaxial Non-Cannulated Screw 10.5x110mm
• 00190837073831: Polyaxial Non-Cannulated Screw, 10.5x100mm
• 00190837036324: Table Mount. Rod Cutter
• 00190837036317: ARX Thoracolumbar Screw Assembly; 8.5mm x 55mm
• 00190837036300: ARX Thoracolumbar Screw Assembly; 8.5mm x 50mm
• 00190837036294: ARX Thoracolumbar Screw Assembly; 8.5mm x 45mm
• 00190837036287: ARX Thoracolumbar Screw Assembly; 8.5mm x 40mm
• 00190837036270: ARX Thoracolumbar Screw Assembly; 8.5mm x 35mm