Centerline Thoracolumbar Spinal System 165-101

GUDID 00190837064495

Modular Tulip Head Screw Inserter

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837064495
• NIH Device Record Key: 846fe3e8-ce54-4bf3-992a-ba7708ad85f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Centerline Thoracolumbar Spinal System
• Version Model Number: 165-101
• Catalog Number: 165-101
• 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	00190837064495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151196

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00190837064495]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [Centerline Thoracolumbar Spinal System]

• 00190837002459: 4085-95-41
• 00190837002442: 4085-90-41
• 00190837002435: 4085-85-41
• 00190837002428: 4085-80-41
• 00190837002411: 4085-75-41
• 00190837002404: 4085-70-41
• 00190837002398: 4085-65-41
• 00190837002381: 4085-60-41
• 00190837002374: 4085-55-41
• 00190837002367: 4085-50-41
• 00190837002350: 4085-45-41
• 00190837002343: 4085-40-41
• 00190837002336: 4085-35-41
• 00190837002329: 4085-30-41
• 00190837002312: 4085-25-41
• 00190837002305: 4085-115-41
• 00190837002299: 4085-105-41
• 00190837002282: 4075-95-41
• 00190837002275: 4075-90-41
• 00190837002268: 4075-85-41
• 00190837002251: 4075-80-41
• 00190837002244: 4075-75-41
• 00190837002237: 4075-70-41
• 00190837002220: 4075-65-41
• 00190837002213: 4075-60-41
• 00190837002206: 4075-125-41
• 00190837002190: 4075-115-41
• 00190837002183: 4075-105-41
• 00190837002176: 4065-95-41
• 00190837002169: 4065-85-41
• 00190837002152: 4065-75-41
• 00190837002145: 4065-65-41
• 00190837002138: 4065-125-41
• 00190837002121: 4065-115-41
• 00190837002114: 4065-105-41
• 00190837002107: 4060-55-41
• 00190837002091: 4060-50-41
• 00190837002084: 4060-45-41
• 00190837002077: 4060-40-41
• 00190837002060: 4060-35-41
• 00190837002053: 4060-30-41
• 00190837002046: 4060-25-41
• 00190837002039: 4055-25-41
• 00190837002022: 4050-55-41
• 00190837002015: 4050-50-41
• 00190837002008: 4050-45-41
• 00190837001995: 4050-40-41
• 00190837001988: 4050-35-41
• 00190837001971: 4050-30-41
• 00190837001964: 4050-25-41