IRIS Anterior Cervical Plate System

GUDID 00190837004491

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00190837004491
• NIH Device Record Key: 03ec77c6-422f-454b-bf69-ef3148c26eba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRIS Anterior Cervical Plate System
• Version Model Number: 438-064
• 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	00190837004491 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130202

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00190837004491]

Moist Heat or Steam Sterilization

[00190837004491]

Moist Heat or Steam Sterilization

[00190837004491]

Moist Heat or Steam Sterilization

[00190837004491]

Moist Heat or Steam Sterilization

[00190837004491]

Moist Heat or Steam Sterilization

[00190837004491]

Moist Heat or Steam Sterilization

[00190837004491]

Moist Heat or Steam Sterilization

[00190837004491]

Moist Heat or Steam Sterilization

[00190837004491]

Moist Heat or Steam Sterilization

[00190837004491]

Moist Heat or Steam Sterilization

[00190837004491]

Moist Heat or Steam Sterilization

[00190837004491]

Moist Heat or Steam Sterilization

[00190837004491]

Moist Heat or Steam Sterilization

[00190837004491]

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: 2016-06-07

On-Brand Devices [IRIS Anterior Cervical Plate System]

• 00190837004576: 448-090
• 00190837004569: 448-086
• 00190837004552: 448-082
• 00190837004545: 448-078
• 00190837004538: 448-074
• 00190837004521: 438-074
• 00190837004514: 438-070
• 00190837004507: 438-067
• 00190837004491: 438-064
• 00190837004484: 438-061
• 00190837004477: 438-058
• 00190837004460: 438-055
• 00190837004453: 438-052
• 00190837004446: 428-050
• 00190837004439: 428-048
• 00190837004422: 428-046
• 00190837004415: 428-044
• 00190837004408: 428-042
• 00190837004392: 428-040
• 00190837004385: 428-038
• 00190837004378: 428-036
• 00190837004361: 428-034
• 00190837004354: 418-034
• 00190837004347: 418-032
• 00190837004330: 418-030
• 00190837004323: 418-028
• 00190837004316: 418-026
• 00190837004309: 418-024
• 00190837004293: 418-022
• 00190837004286: 418-020
• 00190837004279: 157-018
• 00190837004262: 157-016
• 00190837004255: 157-014
• 00190837004248: 157-012
• 00190837004231: 157-010
• 00190837004224: 156-018
• 00190837004217: 156-016
• 00190837004200: 156-014
• 00190837004194: 156-012
• 00190837004187: 156-010
• 00190837004170: 155-018
• 00190837004163: 155-016
• 00190837004156: 155-014
• 00190837004149: 155-012
• 00190837004132: 155-010
• 00190837004125: 154-018
• 00190837004118: 154-016
• 00190837004101: 154-014
• 00190837004095: 154-012
• 00190837004088: 154-010