Plateau V & Z

GUDID 00190837152819

Life Spine, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190837152819
• NIH Device Record Key: f461e998-7af2-4c5c-a870-7e063eaa7bfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plateau V & Z
• Version Model Number: L129-750
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• Device Count: 1
• DM Exempt: false
• 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: false
• 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	00190837152819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182470

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00190837152819]

Moist Heat or Steam Sterilization

[00190837152819]

Moist Heat or Steam Sterilization

[00190837152819]

Moist Heat or Steam Sterilization

[00190837152819]

Moist Heat or Steam Sterilization

[00190837152819]

Moist Heat or Steam Sterilization

[00190837152819]

Moist Heat or Steam Sterilization

[00190837152819]

Moist Heat or Steam Sterilization

[00190837152819]

Moist Heat or Steam Sterilization

[00190837152819]

Moist Heat or Steam Sterilization

[00190837152819]

Moist Heat or Steam Sterilization

[00190837152819]

Moist Heat or Steam Sterilization

[00190837152819]

Moist Heat or Steam Sterilization

[00190837152819]

Moist Heat or Steam Sterilization

[00190837152819]

Moist Heat or Steam Sterilization

[00190837152819]

Moist Heat or Steam Sterilization

[00190837152819]

Moist Heat or Steam Sterilization

[00190837152819]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-25
• Device Publish Date: 2022-11-17

On-Brand Devices [Plateau V & Z]

• 00190837073596: Plateau V Spacer, 12mm x 28mm x 15mm,7 degree
• 00190837073589: Plateau V Spacer, 12mm x 28mm x 14mm,7 degree
• 00190837073572: Plateau V Spacer, 12mm x 28mm x 13mm,7 degree
• 00190837073565: Plateau V Spacer, 12mm x 28mm x 12mm,7 degree
• 00190837073558: 12mm x 28mm x 11mm PLATEAU-V Interbody, 7°, Straight, Bullet
• 00190837073541: Plateau V Spacer, 12mm x 28mm x 10mm,7 degree
• 00190837073534: Plateau V Spacer, 12mm x 28mm x 9mm,7 degree
• 00190837073527: Plateau V Spacer, 12mm x 24mm x 15mm,7 degree
• 00190837073510: Plateau V Spacer, 12mm x 24mm x 14mm,7 degree
• 00190837073503: Plateau V Spacer, 12mm x 24mm x 13mm,7 degree
• 00190837073497: Plateau V Spacer, 12mm x 24mm x 12mm,7 degree
• 00190837073480: Plateau V Spacer, 12mm x 24mm x 11mm,7 degree
• 00190837073473: Plateau V Spacer, 12mm x 24mm x 10mm,7 degree
• 00190837073466: Plateau V Spacer, 12mm x 24mm x 9mm,7 degree
• 00190837073459: Plateau V Spacer, 12mm x 22mm x 14mm,7 degree
• 00190837073442: Plateau V Spacer, 12mm x 22mm x 13mm,7 degree
• 00190837073435: Plateau V Spacer, 12mm x 22mm x 12mm,7 degree
• 00190837073428: Plateau V Spacer, 12mm x 22mm x 11mm,7 degree
• 00190837073411: Plateau V Spacer, 12mm x 22mm x 10mm,7 degree
• 00190837073404: Plateau V Spacer, 12mm x 22mm x 9mm,7 degree
• 00190837073398: Plateau V Spacer, 11mm x 28mm x 14mm,7 degree
• 00190837073374: Plateau V Spacer, 11mm x 28mm x 12mm,7 degree
• 00190837073367: Plateau V Spacer, 11mm x 28mm x 11mm,7 degree
• 00190837073350: Plateau V Spacer, 11mm x 28mm x 10mm,7 degree
• 00190837073343: Plateau V Spacer, 11mm x 28mm x 09mm,7 degree
• 00190837073336: Plateau V Spacer, 11mm x 24mm x 14mm,7 degree
• 00190837073312: Plateau V Spacer, 11mm x 24mm x 12mm,7 degree
• 00190837073299: Plateau V Spacer, 11mm x 24mm x 10mm,7 degree
• 00190837073282: Plateau V Spacer, 11mm x 24mm x 09mm,7 degree
• 00190837073237: Plateau V Spacer, 11mm x 22mm x 10mm,7 degree
• 00190837072643: Bulleted Lordotic PLIF Sizer Body, 16mm, 24mm Length, 7", Mo
• 00190837072636: Bulleted Lordotic PLIF Sizer Body, 15mm, 24mm Length, 7", Mo
• 00190837072629: Bulleted Lordotic PLIF Sizer, 14mm, 20mm length, 7°, Modifie
• 00190837072612: Bulleted Lordotic PLIF Sizer, 13mm, 20mm length, 7°, Modifie
• 00190837072605: Bulleted Lordotic PLIF Sizer, 12mm, 20mm length, 7°, Modifie
• 00190837072599: Bulleted Lordotic PLIF Sizer, 11mm, 20mm length, 7°, Modifie
• 00190837072582: Bulleted Lordotic PLIF Sizer, 10mm, 20mm length, 7°, Modifie
• 00190837072575: Bulleted Lordotic PLIF Sizer, 9mm, 20mm length, 7°, Modified
• 00190837072568: Bulleted PLIF Sizer, 14mm, 32mm Length, 0° Modified Hudson
• 00190837072551: Bulleted PLIF Sizer, 13mm, 32mm Length, 0° Modified Hudson
• 00190837072544: Bulleted PLIF Sizer, 12mm, 32mm Length, 0° Modified Hudson
• 00190837072537: Bulleted PLIF Sizer, 11mm, 32mm Length, 0° Modified Hudson
• 00190837072520: Bulleted PLIF Sizer, 10mm, 32mm Length, 0° Modified Hudson
• 00190837072513: Bulleted PLIF Sizer, 9mm, 32mm Length, 0° Modified Hudson
• 00190837072506: Bulleted PLIF Sizer, 8mm, 32mm Length, 0° Modified Hudson
• 00190837072490: Bulleted PLIF Sizer, 7mm, 32mm Length, 0° Modified Hudson
• 00190837072483: Bulleted PLIF Sizer, 6mm, 32mm Length, 0° Modified Hudson
• 00190837072476: Bulleted PLIF Sizer, 16mm, 30mm Length, 0° Modified Hudson D
• 00190837072469: Bulleted PLIF Sizer, 15mm, 30mm Length, 0° Modified Hudson D
• 00190837072452: Bulleted PLIF Sizer, 14mm, 30mm Length, 0° Modified Hudson