NEO UL Anterior Cervical Plate System

GUDID 00190837008543

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837008543
• NIH Device Record Key: 20c63f28-c1e9-48bd-8a5e-66e72671095c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEO UL Anterior Cervical Plate System
• Version Model Number: 325-018
• 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	00190837008543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103423

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00190837008543]

Moist Heat or Steam Sterilization

[00190837008543]

Moist Heat or Steam Sterilization

[00190837008543]

Moist Heat or Steam Sterilization

[00190837008543]

Moist Heat or Steam Sterilization

[00190837008543]

Moist Heat or Steam Sterilization

[00190837008543]

Moist Heat or Steam Sterilization

[00190837008543]

Moist Heat or Steam Sterilization

[00190837008543]

Moist Heat or Steam Sterilization

[00190837008543]

Moist Heat or Steam Sterilization

[00190837008543]

Moist Heat or Steam Sterilization

[00190837008543]

Moist Heat or Steam Sterilization

[00190837008543]

Moist Heat or Steam Sterilization

[00190837008543]

Moist Heat or Steam Sterilization

[00190837008543]

Moist Heat or Steam Sterilization

[00190837008543]

Moist Heat or Steam Sterilization

[00190837008543]

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 UL Anterior Cervical Plate System]

• 00190837008697: 328-018
• 00190837008680: 328-016
• 00190837008673: 328-014
• 00190837008666: 328-012
• 00190837008659: 328-010
• 00190837008642: 327-018
• 00190837008635: 327-016
• 00190837008628: 327-014
• 00190837008611: 327-012
• 00190837008604: 327-010
• 00190837008598: 326-018
• 00190837008581: 326-016
• 00190837008574: 326-014
• 00190837008567: 326-012
• 00190837008550: 326-010
• 00190837008543: 325-018
• 00190837008536: 325-016
• 00190837008529: 325-014
• 00190837008512: 325-012
• 00190837008505: 325-010
• 00190837008499: 145-248
• 00190837008482: 145-246
• 00190837008475: 145-244
• 00190837008468: 145-242
• 00190837008451: 145-240
• 00190837008444: 145-238
• 00190837008437: 145-128
• 00190837008420: 145-126
• 00190837008413: 145-124
• 00190837008406: 145-122
• 00190837008390: 145-120
• 00190837044893: Custom NEO UL Driver
• 00190837045074: 4.85mm x18mm, Neo UL FA/SD Emergency FT Bone Screw
• 00190837045067: 4.85mm x16mm, Neo UL FA/SD Emergency FT Bone Screw
• 00190837045050: 4.85mm x14mm, Neo UL FA/SD Emergency FT Bone Screw
• 00190837045043: 4.85mm x12mm, Neo UL FA/SD Emergency FT Bone Screw
• 00190837045036: 4.85mm x10mm, Neo UL FA/SD Emergency FT Bone Screw
• 00190837045029: 4.85mm x16mm, Neo UL VA/SD FT Bone Screw
• 00190837045012: 4.85mm x14mm, Neo UL VA/SD FT Bone Screw
• 00190837045005: 4.85mm x12mm, Neo UL VA/SD FT Bone Screw
• 00190837044992: 4.85mm x10mm, Neo UL VA/SD FT Bone Screw
• 00190837044985: 4.5mm x16mm, Neo UL VA/SD FT Bone Screw
• 00190837044978: 4.5mm x14mm, Neo UL VA/SD FT Bone Screw
• 00190837044961: 4.5mm x12mm, Neo UL VA/SD FT Bone Screw
• 00190837044954: 4.5mm x10mm, Neo UL VA/SD FT Bone Screw
• 00190837044947: 4.5mm x18mm, Neo UL FA/SD FT Bone Screw
• 00190837044930: 4.5mm x16mm, Neo UL FA/SD FT Bone Screw
• 00190837044923: 4.5mm x14mm, Neo UL FA/SD FT Bone Screw
• 00190837044916: 4.5mm x12mm, Neo UL FA/SD FT Bone Screw
• 00190837044909: 4.5mm x10mm, Neo UL FA/SD FT Bone Screw