Plateau-V Spacer System

GUDID 00190837011802

Life Spine, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190837011802
• NIH Device Record Key: 65ecb6b2-f636-41af-af02-d4efb982a81e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plateau-V Spacer System
• Version Model Number: 61-1228-714
• 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	00190837011802 [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

[00190837011802]

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: 2016-06-09

On-Brand Devices [Plateau-V Spacer System]

• 00190837011857: 61-1224-715
• 00190837011840: 61-1224-714
• 00190837011833: 61-1224-713
• 00190837011826: 61-1224-712
• 00190837011819: 61-1228-715
• 00190837011802: 61-1228-714
• 00190837011796: 61-1228-713
• 00190837011789: 61-1228-712
• 00190837029203: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 32mm x 18mm, 7°
• 00190837029197: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 32mm x 17mm, 7°
• 00190837029180: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 32mm x 16mm, 7°
• 00190837029173: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 32mm x 15mm, 7°
• 00190837029166: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 32mm x 14mm, 7°
• 00190837029159: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 32mm x 13mm, 7°
• 00190837029142: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 32mm x 12mm, 7°
• 00190837029135: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 30mm x 18mm, 7°
• 00190837029128: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 30mm x 17mm, 7°
• 00190837029111: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 30mm x 16mm, 7°
• 00190837029104: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 30mm x 15mm, 7°
• 00190837029098: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 30mm x 14mm, 7°
• 00190837029081: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 30mm x 13mm, 7°
• 00190837029074: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 30mm x 12mm, 7°
• 00190837029067: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 28mm x 18mm, 7°
• 00190837029050: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 28mm x 17mm, 7°
• 00190837029043: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 28mm x 16mm, 7°
• 00190837029036: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 26mm x 18mm, 7°
• 00190837029029: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 26mm x 17mm, 7°
• 00190837029012: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 26mm x 16mm, 7°
• 00190837029005: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 26mm x 15mm, 7°
• 00190837028992: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 26mm x 14mm, 7°
• 00190837028985: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 26mm x 13mm, 7°
• 00190837028978: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 26mm x 12mm, 7°
• 00190837028961: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 24mm x 18mm, 7°
• 00190837028954: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 24mm x 17mm, 7°
• 00190837028947: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 24mm x 16mm, 7°
• 00190837028930: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 22mm x 18mm, 7°
• 00190837028923: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 22mm x 17mm, 7°
• 00190837028916: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 22mm x 16mm, 7°
• 00190837028909: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 22mm x 15mm, 7°
• 00190837028893: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 22mm x 14mm, 7°
• 00190837028886: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 22mm x 13mm, 7°
• 00190837028879: PLATEAU-V Interbody, Straight, Bulleted, 12mm x 22mm x 12mm, 7°