PLATEAU-TL 51-1030-16

GUDID 00190837028596

PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 30mm x 16mm, 0°

Life Spine, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190837028596
• NIH Device Record Key: 436a097b-60ee-4f12-906b-e8c6087f54b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLATEAU-TL
• Version Model Number: 51-1030-16
• Catalog Number: 51-1030-16
• 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: 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	00190837028596 [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

[00190837028596]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-11-14

On-Brand Devices [PLATEAU-TL]

• 00190837028862: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 34mm x 18mm, 0°
• 00190837028855: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 34mm x 17mm, 0°
• 00190837028848: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 34mm x 16mm, 0°
• 00190837028831: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 34mm x 15mm, 0°
• 00190837028824: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 34mm x 14mm, 0°
• 00190837028817: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 34mm x 13mm, 0°
• 00190837028800: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 34mm x 12mm, 0°
• 00190837028794: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 34mm x 11mm, 0°
• 00190837028787: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 34mm x 10mm, 0°
• 00190837028770: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 34mm x 9mm, 0°
• 00190837028763: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 34mm x 8mm, 0°
• 00190837028756: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 34mm x 7mm, 0°
• 00190837028749: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 34mm x 6mm, 0°
• 00190837028732: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 32mm x 18mm, 0°
• 00190837028725: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 32mm x 17mm, 0°
• 00190837028718: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 32mm x 16mm, 0°
• 00190837028701: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 32mm x 15mm, 0°
• 00190837028695: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 32mm x 13mm, 0°
• 00190837028688: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 32mm x 12mm, 0°
• 00190837028671: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 32mm x 11mm, 0°
• 00190837028664: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 32mm x 10mm, 0°
• 00190837028657: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 32mm x 9mm, 0°
• 00190837028640: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 32mm x 8mm, 0°
• 00190837028633: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 32mm x 7mm, 0°
• 00190837028626: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 32mm x 6mm, 0°
• 00190837028619: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 30mm x 18mm, 0°
• 00190837028602: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 30mm x 17mm, 0°
• 00190837028596: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 30mm x 16mm, 0°
• 00190837028589: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 30mm x 15mm, 0°
• 00190837028572: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 30mm x 14mm, 0°
• 00190837028565: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 30mm x 13mm, 0°
• 00190837028558: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 30mm x 12mm, 0°
• 00190837028541: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 30mm x 11mm, 0°
• 00190837028534: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 30mm x 10mm, 0°
• 00190837028527: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 30mm x 9mm, 0°
• 00190837028510: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 30mm x 8mm, 0°
• 00190837028503: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 30mm x 7mm, 0°
• 00190837028497: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 30mm x 6mm, 0°
• 00190837028480: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 28mm x 18mm, 0°
• 00190837028473: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 28mm x 17mm, 0°
• 00190837028466: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 28mm x 16mm, 0°
• 00190837028459: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 28mm x 15mm, 0°
• 00190837028428: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 26mm x 18mm, 0°
• 00190837028411: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 26mm x 17mm, 0°
• 00190837028404: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 26mm x 16mm, 0°
• 00190837028398: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 26mm x 15mm, 0°
• 00190837028381: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 26mm x 14mm, 0°
• 00190837028374: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 26mm x 13mm, 0°
• 00190837028367: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 26mm x 12mm, 0°
• 00190837028350: PLATEAU-TL Interbody, Convex, Bulleted, 10mm x 26mm x 11mm, 0°