NEO SL/Kinetic SL Anterior Cervical Plate System

GUDID 00190837005542

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837005542
• NIH Device Record Key: 95662592-6c01-4c2d-9faf-6c91f2e9cab7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEO SL/Kinetic SL Anterior Cervical Plate System
• Version Model Number: 302-018
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• Device Count: 1
• DM Exempt: true
• 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	00190837005542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073479

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00190837005542]

Moist Heat or Steam Sterilization

[00190837005542]

Moist Heat or Steam Sterilization

[00190837005542]

Moist Heat or Steam Sterilization

[00190837005542]

Moist Heat or Steam Sterilization

[00190837005542]

Moist Heat or Steam Sterilization

[00190837005542]

Moist Heat or Steam Sterilization

[00190837005542]

Moist Heat or Steam Sterilization

[00190837005542]

Moist Heat or Steam Sterilization

[00190837005542]

Moist Heat or Steam Sterilization

[00190837005542]

Moist Heat or Steam Sterilization

[00190837005542]

Moist Heat or Steam Sterilization

[00190837005542]

Moist Heat or Steam Sterilization

[00190837005542]

Moist Heat or Steam Sterilization

[00190837005542]

Moist Heat or Steam Sterilization

[00190837005542]

Moist Heat or Steam Sterilization

[00190837005542]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-14

On-Brand Devices [NEO SL/Kinetic SL Anterior Cervical Plate System]

• 00190837005757: 306-018
• 00190837005740: 306-016
• 00190837005733: 306-014
• 00190837005726: 306-012
• 00190837005719: 306-010
• 00190837005702: 305-018
• 00190837005696: 305-016
• 00190837005689: 305-014
• 00190837005672: 305-012
• 00190837005665: 305-010
• 00190837005597: 303-018
• 00190837005580: 303-016
• 00190837005573: 303-014
• 00190837005566: 303-012
• 00190837005559: 303-010
• 00190837005542: 302-018
• 00190837005535: 302-016
• 00190837005528: 302-014
• 00190837005511: 302-012
• 00190837005504: 302-010
• 00190837005498: 301-018
• 00190837005481: 301-016
• 00190837005474: 301-014
• 00190837005467: 301-012
• 00190837005450: 301-010
• 00190837024413: NEO-SL/KINETIC-SL Bone Screw, Emergency, Variable Angle, Sharp Tip, 4.3mm x 18mm
• 00190837024406: NEO-SL/KINETIC-SL Bone Screw, Emergency, Variable Angle, Sharp Tip, 4.3mm x 16mm
• 00190837024390: NEO-SL/KINETIC-SL Bone Screw, Emergency, Variable Angle, Sharp Tip, 4.3mm x 14mm
• 00190837024383: NEO-SL/KINETIC-SL Bone Screw, Emergency, Variable Angle, Sharp Tip, 4.3mm x 12mm
• 00190837024376: NEO-SL/KINETIC-SL Bone Screw, Emergency, Variable Angle, Sharp Tip, 4.3mm x 10mm