Arx MIS

GUDID 00190837144678

Life Spine, Inc.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00190837144678
• NIH Device Record Key: 79789692-893f-48a3-8361-51e8c6542ae2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arx MIS
• Version Model Number: 12-4535-03
• 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: true
• 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	00190837144678 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233455

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-19
• Device Publish Date: 2026-02-11

On-Brand Devices [Arx MIS]

• 00190837171537: 175-045
• 00190837144951: 12-8555-03
• 00190837144944: 12-8550-03
• 00190837144937: 12-8545-03
• 00190837144920: 12-8540-03
• 00190837144913: 12-8535-03
• 00190837144906: 12-8530-03
• 00190837144890: 12-7555-03
• 00190837144883: 12-7550-03
• 00190837144876: 12-7545-03
• 00190837144869: 12-7540-03
• 00190837144852: 12-7535-03
• 00190837144845: 12-7530-03
• 00190837144838: 12-6555-03
• 00190837144821: 12-6550-03
• 00190837144814: 12-6545-03
• 00190837144807: 12-6540-03
• 00190837144791: 12-6535-03
• 00190837144784: 12-6530-03
• 00190837144777: 12-5555-03
• 00190837144760: 12-5550-03
• 00190837144753: 12-5545-03
• 00190837144746: 12-5540-03
• 00190837144739: 12-5535-03
• 00190837144722: 12-5530-03
• 00190837144715: 12-4555-03
• 00190837144708: 12-4550-03
• 00190837144692: 12-4545-03
• 00190837144685: 12-4540-03
• 00190837144678: 12-4535-03
• 00190837144661: 12-4530-03