Modular Fixation System 112-300

GUDID 00190837076139

SMALL AO RATCHET HANDLE

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837076139
• NIH Device Record Key: 5959e710-d440-44c3-9463-5aa0992f9b65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modular Fixation System
• Version Model Number: 112-300
• Catalog Number: 112-300
• 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	00190837076139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183430

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00190837076139]

Moist Heat or Steam Sterilization

[00190837076139]

Moist Heat or Steam Sterilization

[00190837076139]

Moist Heat or Steam Sterilization

[00190837076139]

Moist Heat or Steam Sterilization

[00190837076139]

Moist Heat or Steam Sterilization

[00190837076139]

Moist Heat or Steam Sterilization

[00190837076139]

Moist Heat or Steam Sterilization

[00190837076139]

Moist Heat or Steam Sterilization

[00190837076139]

Moist Heat or Steam Sterilization

[00190837076139]

Moist Heat or Steam Sterilization

[00190837076139]

Moist Heat or Steam Sterilization

[00190837076139]

Moist Heat or Steam Sterilization

[00190837076139]

Moist Heat or Steam Sterilization

[00190837076139]

Moist Heat or Steam Sterilization

[00190837076139]

Moist Heat or Steam Sterilization

[00190837076139]

Moist Heat or Steam Sterilization

[00190837076139]

Moist Heat or Steam Sterilization

[00190837076139]

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 [Modular Fixation System]

• 00190837076771: Bone Screw, 7.5mm x 55mm, Noncannulated
• 00190837076764: Bone Screw, 7.5mm x 50mm, Noncannulated
• 00190837076757: Bone Screw, 7.5mm x 45mm, Noncannulated
• 00190837076740: Bone Screw, 7.5mm x 40mm, Noncannulated
• 00190837076733: Bone Screw, 7.5mm x 35mm, Noncannulated
• 00190837076726: Bone Screw, 7.5mm x 30mm, Noncannulated
• 00190837076719: Bone Screw, 7.5mm x 25mm, Noncannulated
• 00190837076702: Bone Screw, 6.5mm x 55mm, Noncannulated
• 00190837076696: Bone Screw, 6.5mm x 50mm, Noncannulated
• 00190837076689: Bone Screw, 6.5mm x 45mm, Noncannulated
• 00190837076672: Bone Screw, 6.5mm x 40mm, Noncannulated
• 00190837076665: Bone Screw, 6.5mm x 35mm, Noncannulated
• 00190837076658: Bone Screw, 6.5mm x 30mm, Noncannulated
• 00190837076641: Bone Screw, 6.5mm x 25mm, Noncannulated
• 00190837076634: Bone Screw, 5.5mm x 55mm, Noncannulated
• 00190837076627: Bone Screw, 5.5mm x 50mm, Noncannulated
• 00190837076610: Bone Screw, 5.5mm x 45mm, Noncannulated
• 00190837076603: Bone Screw, 5.5mm x 40mm, Noncannulated
• 00190837076597: Bone Screw, 5.5mm x 35mm, Noncannulated
• 00190837076580: Bone Screw, 5.5mm x 30mm, Noncannulated
• 00190837076573: Bone Screw, 5.5mm x 25mm, Noncannulated
• 00190837076566: Bone Screw, 5.0mm x 50mm, Noncannulated
• 00190837076559: Bone Screw, 5.0mm x 45mm, Noncannulated
• 00190837076542: Bone Screw, 5.0mm x 40mm, Noncannulated
• 00190837076535: Bone Screw, 5.0mm x 35mm, Noncannulated
• 00190837076528: Bone Screw, 5.0mm x 30mm, Noncannulated
• 00190837076511: Bone Screw, 5.0mm x 25mm, Noncannulated
• 00190837076504: Bone Screw, 4.5mm x 55mm, Noncannulated
• 00190837076498: Bone Screw, 4.5mm x 50mm, Noncannulated
• 00190837076481: Bone Screw, 4.5mm x 45mm, Noncannulated
• 00190837076474: Bone Screw, 4.5mm x 40mm, Noncannulated
• 00190837076467: Bone Screw, 4.5mm x 35mm, Noncannulated
• 00190837076450: Bone Screw, 4.5mm x 30mm, Noncannulated
• 00190837076443: Bone Screw, 4.5mm x 25mm, Noncannulated
• 00190837076429: 1/4 Square Distractor Driver
• 00190837076405: Modular Tip - Lamina Spreader - Left
• 00190837076399: Modular Tip - Shank Distraction - Right
• 00190837076351: 360 Cortical Reamer
• 00190837076313: 4.75mm Rod Caddy
• 00190837076306: Centerline Drill for 7.5mm Screw
• 00190837086077: Threaded Tulip Inserter with Verifier
• 00190837076436: Modular Tulip Head, 4.0mm-7.5mm
• 00190837076412: Modular Tip - Lamina Spreader - Right
• 00190837076382: Modular Tip - Shank Distraction - Left
• 00190837076375: Screw Distractor
• 00190837076368: Bottom Cutting Cortical Reamer
• 00190837076344: Threaded Tulip Inserter
• 00190837076337: Forceps-Style Tulip Inserter
• 00190837076320: Modular Screwdriver
• 00190837076290: Centerline Depth Stop, Adjustable Drill Guide