ARx MIS

GUDID 00190837171537

Life Spine, Inc.

Spinal bone screw head/rod adaptor

• Primary Device ID: 00190837171537
• NIH Device Record Key: 07577d2b-3277-457d-88a3-04ede37e2fd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARx MIS
• Version Model Number: 175-045
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837171537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233455

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00190837171537]

Moist Heat or Steam Sterilization

[00190837171537]

Moist Heat or Steam Sterilization

[00190837171537]

Moist Heat or Steam Sterilization

[00190837171537]

Moist Heat or Steam Sterilization

[00190837171537]

Moist Heat or Steam Sterilization

[00190837171537]

Moist Heat or Steam Sterilization

[00190837171537]

Moist Heat or Steam Sterilization

[00190837171537]

Moist Heat or Steam Sterilization

[00190837171537]

Moist Heat or Steam Sterilization

[00190837171537]

Moist Heat or Steam Sterilization

[00190837171537]

Moist Heat or Steam Sterilization

[00190837171537]

Moist Heat or Steam Sterilization

[00190837171537]

Moist Heat or Steam Sterilization

[00190837171537]

Moist Heat or Steam Sterilization

[00190837171537]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-07
• Device Publish Date: 2025-02-27

Devices Manufactured by Life Spine, Inc.

• 00190837171537 - ARx MIS: 2025-03-07
• 00190837171537 - ARx MIS: 2025-03-07
• 00190837205034 - ARx: 2025-01-16
• 00190837205041 - ARx: 2025-01-16
• 00190837175405 - ARx SAI: 2025-01-13
• 00190837175429 - ARx SAI: 2025-01-13
• 00190837175443 - ARx SAI: 2025-01-13
• 00190837175610 - ARx SAI: 2025-01-13
• 00190837175634 - ARx SAI: 2025-01-13