Centerline 2019-0084

GUDID 00190837096205

Tap Distractor

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837096205
• NIH Device Record Key: 3bf7c0d4-559f-48b1-8cb0-0b359c000a18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Centerline
• Version Model Number: 2019-0084
• Catalog Number: 2019-0084
• 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	00190837096205 [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

[00190837096205]

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]

• 00190837089207: T25 Polyaxial Screwdriver, Cannulated
• 00190837085643: 4.75mm Rod Pusher
• 00190837085407: 4.75mm Rod/Cross Connector Holder
• 00190837096205: Tap Distractor
• 00190837094027: Modular Extended Tab Tulip Head, 4.0mm-7.5mm
• 00190837094010: Extended Tab Tulip Caddy
• 00190837085650: Tap Distractor
• 00190837085391: 5.5mm In Situ Rod Bender
• 00190837085384: 5.5mm In Situ Rod Bender
• 00190837105549: Centerline GX ø7.5mm Tap, Cannulated
• 00190837105532: Centerline GX ø6.5mm Tap, Cannulated
• 00190837105525: Centerline GX ø6.0mm Tap, Cannulated
• 00190837105518: Centerline GX ø5.5mm Tap, Cannulated
• 00190837105501: Centerline GX ø5.0mm Tap, Cannulated
• 00190837105495: Centerline GX ø4.5mm Tap, Cannulated
• 00190837105488: Centerline GX ø6.0mm Tap, Noncannulated
• 00190837102623: T25 Polyaxial Screwdriver, Non-Cannulated, Power
• 00190837102616: T25 Polyaxial Screwdriver, Cannulated, Power
• 00190837102609: T25 Polyaxial Screwdriver, Non-Cannulated, Reduction
• 00190837102593: T25 Polyaxial Screwdriver, Cannulated, Reduction