Neo-SL 304-016

GUDID 00190837036867

16mm Fixed Screw, D=4.3mm, SL-FT

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00190837036867
• NIH Device Record Key: d9717a65-2609-4d3d-bb1a-494bcc93f61e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neo-SL
• Version Model Number: 304-016
• Catalog Number: 304-016
• 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: 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	00190837036867 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070285

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00190837036867]

Moist Heat or Steam Sterilization

[00190837036867]

Moist Heat or Steam Sterilization

[00190837036867]

Moist Heat or Steam Sterilization

[00190837036867]

Moist Heat or Steam Sterilization

[00190837036867]

Moist Heat or Steam Sterilization

[00190837036867]

Moist Heat or Steam Sterilization

[00190837036867]

Moist Heat or Steam Sterilization

[00190837036867]

Moist Heat or Steam Sterilization

[00190837036867]

Moist Heat or Steam Sterilization

[00190837036867]

Moist Heat or Steam Sterilization

[00190837036867]

Moist Heat or Steam Sterilization

[00190837036867]

Moist Heat or Steam Sterilization

[00190837036867]

Moist Heat or Steam Sterilization

[00190837036867]

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 [Neo-SL]

• 00190837036874: 18mm Fixed Screw, D=4.3mm, SL-FT
• 00190837036867: 16mm Fixed Screw, D=4.3mm, SL-FT
• 00190837036850: 14mm Fixed Screw, D=4.3mm, SL-FT
• 00190837036843: 12mm Fixed Screw, D=4.3mm, SL-FT
• 00190837036836: 114-800
• 00190837036829: 114-011
• 00190837036812: NEO SL 1-3 Level ACP Block