AVATAR Minimally Invasive Spinal System

GUDID 00190837000646

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837000646
• NIH Device Record Key: 4f2cbfb5-af30-4f3d-bfad-79c066c31fe5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVATAR Minimally Invasive Spinal System
• Version Model Number: 255-50-53
• 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	00190837000646 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111953

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

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

[00190837000646]

Moist Heat or Steam Sterilization

[00190837000646]

Moist Heat or Steam Sterilization

[00190837000646]

Moist Heat or Steam Sterilization

[00190837000646]

Moist Heat or Steam Sterilization

[00190837000646]

Moist Heat or Steam Sterilization

[00190837000646]

Moist Heat or Steam Sterilization

[00190837000646]

Moist Heat or Steam Sterilization

[00190837000646]

Moist Heat or Steam Sterilization

[00190837000646]

Moist Heat or Steam Sterilization

[00190837000646]

Moist Heat or Steam Sterilization

[00190837000646]

Moist Heat or Steam Sterilization

[00190837000646]

Moist Heat or Steam Sterilization

[00190837000646]

Moist Heat or Steam Sterilization

[00190837000646]

Moist Heat or Steam Sterilization

[00190837000646]

Moist Heat or Steam Sterilization

[00190837000646]

Moist Heat or Steam Sterilization

[00190837000646]

Moist Heat or Steam Sterilization

[00190837000646]

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: 2016-06-08

On-Brand Devices [AVATAR Minimally Invasive Spinal System]

• 00190837001469: 3555-200
• 00190837001452: 3555-190
• 00190837001445: 3555-180
• 00190837001438: 3555-170
• 00190837001421: 3555-160
• 00190837001414: 3555-150
• 00190837001407: 3555-140
• 00190837001391: 7245-55-55
• 00190837001384: 7245-50-55
• 00190837001377: 7245-45-55
• 00190837001360: 7245-40-55
• 00190837001353: 7245-35-55
• 00190837001346: 7245-30-55
• 00190837001339: 4551-135
• 00190837001322: 4551-130
• 00190837001315: 4551-125
• 00190837001308: 4551-120
• 00190837001292: 4551-115
• 00190837001285: 4551-110
• 00190837001278: 4551-105
• 00190837001261: 4551-100
• 00190837001254: 4551-095
• 00190837001247: 7275-55-55
• 00190837001230: 7275-50-55
• 00190837001223: 7275-45-55
• 00190837001216: 7275-40-55
• 00190837001209: 7275-35-55
• 00190837001193: 7275-30-55
• 00190837001186: 7265-55-55
• 00190837001179: 7265-50-55
• 00190837001162: 7265-45-55
• 00190837001155: 7265-40-55
• 00190837001148: 7265-35-55
• 00190837001131: 7265-30-55
• 00190837001124: 7255-55-55
• 00190837001117: 7255-50-55
• 00190837001100: 7255-45-55
• 00190837001094: 7255-40-55
• 00190837001087: 7255-35-55
• 00190837001070: 7255-30-55
• 00190837001063: 4551-090
• 00190837001056: 4551-085
• 00190837001049: 4551-080
• 00190837001032: 4551-075
• 00190837001025: 4551-070
• 00190837001018: 4551-065
• 00190837001001: 4551-060
• 00190837000998: 4551-055
• 00190837000981: 4551-050
• 00190837000974: 4551-045