Plateau-X Spacer System

GUDID 00190837016470

Life Spine, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190837016470
• NIH Device Record Key: fe96af73-c55d-405a-8585-3b9d1017af69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plateau-X Spacer System
• Version Model Number: 89-2260-008
• 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	00190837016470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121116

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00190837016470]

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-X Spacer System]

• 00190837017569: 89-1845-010
• 00190837017552: 89-1845-008
• 00190837017545: 89-1840-716
• 00190837017538: 89-1840-714
• 00190837017521: 89-1840-712
• 00190837017514: 89-1840-710
• 00190837017507: 89-1840-708
• 00190837017491: 89-1840-016
• 00190837017484: 89-1840-014
• 00190837017477: 89-1840-012
• 00190837017460: 89-1840-010
• 00190837017453: 89-1840-008
• 00190837016562: 89-2260-716
• 00190837016555: 89-2260-714
• 00190837016548: 89-2260-712
• 00190837016531: 89-2260-710
• 00190837016524: 89-2260-708
• 00190837016517: 89-2260-016
• 00190837016500: 89-2260-014
• 00190837016494: 89-2260-012
• 00190837016487: 89-2260-010
• 00190837016470: 89-2260-008
• 00190837016463: 89-2255-716
• 00190837016456: 89-2255-714
• 00190837016449: 89-2255-712
• 00190837016432: 89-2255-710
• 00190837016425: 89-2255-708
• 00190837016418: 89-2255-016
• 00190837016401: 89-2255-014
• 00190837016395: 89-2255-012
• 00190837016388: 89-2255-010
• 00190837016371: 89-2255-008
• 00190837016364: 89-2250-716
• 00190837016357: 89-2250-714
• 00190837016333: 89-2250-710
• 00190837016326: 89-2250-708
• 00190837016319: 89-2250-016
• 00190837016302: 89-2250-014
• 00190837016296: 89-2250-012
• 00190837016289: 89-2250-010
• 00190837016272: 89-2250-008
• 00190837016265: 89-2245-716
• 00190837016258: K121116
• 00190837016241: 89-2245-712
• 00190837016234: 89-2245-710
• 00190837016210: 89-2245-016
• 00190837016203: 89-2245-014
• 00190837016197: 89-2245-012
• 00190837016180: 89-2245-010
• 00190837016173: 89-2245-008