Plateau-LO Spacer System

GUDID 00190837015671

Life Spine, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190837015671
• NIH Device Record Key: de76d62e-5511-4867-890b-82b61609f62a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plateau-LO Spacer System
• Version Model Number: 46-1042-1210
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837015671 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111569

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00190837015671]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-12-19

On-Brand Devices [Plateau-LO Spacer System]

• 00190837015688: 46-1042-1212
• 00190837015671: 46-1042-1210
• 00190837015664: 46-1042-1208
• 00190837015657: 46-1042-712
• 00190837015640: 46-1042-710
• 00190837015633: 46-1042-708
• 00190837015626: 46-1036-1212
• 00190837015619: 46-1036-1210
• 00190837015602: 46-1036-1208
• 00190837015596: 46-1036-712
• 00190837015589: 46-1036-710
• 00190837015572: 46-1036-708
• 00190837028237: PLATEAU-LO Interbody, 10mm x 32mm x 9mm, 12°
• 00190837028220: PLATEAU-LO Interbody, 10mm x 32mm x 8mm, 12°
• 00190837028213: PLATEAU-LO Interbody, 10mm x 30mm x 14mm, 12°
• 00190837028206: PLATEAU-LO Interbody, 10mm x 30mm x 13mm, 12°
• 00190837028183: PLATEAU-LO Interbody, 10mm x 30mm x 11mm, 12°
• 00190837028169: PLATEAU-LO Interbody, 10mm x 30mm x 9mm, 12°
• 00190837028145: PLATEAU-LO Interbody, 10mm x 28mm x 14mm, 12°
• 00190837028138: PLATEAU-LO Interbody, 10mm x 28mm x 13mm, 12°
• 00190837028114: PLATEAU-LO Interbody, 10mm x 28mm x 11mm, 12°
• 00190837028091: PLATEAU-LO Interbody, 10mm x 28mm x 9mm, 12°
• 00190837028077: PLATEAU-LO Interbody, 10mm x 26mm x 14mm, 12°
• 00190837028060: PLATEAU-LO Interbody, 10mm x 26mm x 13mm, 12°
• 00190837028053: PLATEAU-LO Interbody, 10mm x 26mm x 12mm, 12°
• 00190837028046: PLATEAU-LO Interbody, 10mm x 26mm x 11mm, 12°
• 00190837028039: PLATEAU-LO Interbody, 10mm x 26mm x 10mm, 12°
• 00190837028022: PLATEAU-LO Interbody, 10mm x 26mm x 9mm, 12°
• 00190837028015: PLATEAU-LO Interbody, 10mm x 26mm x 8mm, 12°
• 00190837028008: PLATEAU-LO Interbody, 10mm x 24mm x 14mm, 12°
• 00190837027995: PLATEAU-LO Interbody, 10mm x 24mm x 13mm, 12°
• 00190837027971: PLATEAU-LO Interbody, 10mm x 24mm x 11mm, 12°
• 00190837027957: PLATEAU-LO Interbody, 10mm x 24mm x 9mm, 12°
• 00190837027933: PLATEAU-LO Interbody, 10mm x 42mm x 14mm, 7°
• 00190837027926: PLATEAU-LO Interbody, 10mm x 42mm x 13mm, 7°
• 00190837027919: PLATEAU-LO Interbody, 10mm x 42mm x 11mm, 7°
• 00190837027902: PLATEAU-LO Interbody, 10mm x 42mm x 9mm, 7°
• 00190837027896: PLATEAU-LO Interbody, 10mm x 40mm x 14mm, 7°
• 00190837027889: PLATEAU-LO Interbody, 10mm x 40mm x 13mm, 7°
• 00190837027872: PLATEAU-LO Interbody, 10mm x 40mm x 12mm, 7°
• 00190837027865: PLATEAU-LO Interbody, 10mm x 40mm x 11mm, 7°
• 00190837027858: PLATEAU-LO Interbody, 10mm x 40mm x 10mm, 7°
• 00190837027841: PLATEAU-LO Interbody, 10mm x 40mm x 9mm, 7°
• 00190837027834: PLATEAU-LO Interbody, 10mm x 40mm x 8mm, 7°
• 00190837027827: PLATEAU-LO Interbody, 10mm x 38mm x 14mm, 7°
• 00190837027810: PLATEAU-LO Interbody, 10mm x 38mm x 13mm, 7°
• 00190837027803: PLATEAU-LO Interbody, 10mm x 38mm x 12mm, 7°
• 00190837027797: PLATEAU-LO Interbody, 10mm x 38mm x 11mm, 7°
• 00190837027780: PLATEAU-LO Interbody, 10mm x 38mm x 10mm, 7°
• 00190837027773: PLATEAU-LO Interbody, 10mm x 38mm x 9mm, 7°