Plateau-C Ti 113-1035

GUDID 00190837066512

16x13 Rasp/Trial 0 deg 5mm No Stop

Life Spine, Inc.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00190837066512
• NIH Device Record Key: 62d17323-1108-465f-9433-eec96c230f56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plateau-C Ti
• Version Model Number: 113-1035
• Catalog Number: 113-1035
• 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	00190837066512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161127

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[00190837066512]

Moist Heat or Steam Sterilization

[00190837066512]

Moist Heat or Steam Sterilization

[00190837066512]

Moist Heat or Steam Sterilization

[00190837066512]

Moist Heat or Steam Sterilization

[00190837066512]

Moist Heat or Steam Sterilization

[00190837066512]

Moist Heat or Steam Sterilization

[00190837066512]

Moist Heat or Steam Sterilization

[00190837066512]

Moist Heat or Steam Sterilization

[00190837066512]

Moist Heat or Steam Sterilization

[00190837066512]

Moist Heat or Steam Sterilization

[00190837066512]

Moist Heat or Steam Sterilization

[00190837066512]

Moist Heat or Steam Sterilization

[00190837066512]

Moist Heat or Steam Sterilization

[00190837066512]

Moist Heat or Steam Sterilization

[00190837066512]

Moist Heat or Steam Sterilization

[00190837066512]

Moist Heat or Steam Sterilization

[00190837066512]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [Plateau-C Ti]

• 00190837019754: 36-1613-212T
• 00190837019747: 36-1613-211T
• 00190837019730: 36-1613-210T
• 00190837019723: 36-1613-209T
• 00190837019716: 36-1613-208T
• 00190837019709: 36-1613-207T
• 00190837019693: 36-1613-206T
• 00190837019686: 36-1613-205T
• 00190837019679: 37-1613-712T
• 00190837019662: 37-1613-711T
• 00190837019655: 37-1613-710T
• 00190837019648: 37-1613-709T
• 00190837019631: 37-1613-708T
• 00190837019624: 37-1613-707T
• 00190837019617: 37-1613-706T
• 00190837019600: 37-1613-705T
• 00190837019594: 36-1613-12T
• 00190837019587: 36-1613-11T
• 00190837019570: 36-1613-10T
• 00190837019563: 36-1613-09T
• 00190837019556: 36-1613-08T
• 00190837019549: 36-1613-07T
• 00190837019532: 36-1613-06T
• 00190837019525: 36-1613-05T
• 00190837019518: 36-1411-212T
• 00190837019501: 36-1411-211T
• 00190837019495: 36-1411-210T
• 00190837019488: 36-1411-209T
• 00190837019471: 36-1411-208T
• 00190837019464: 36-1411-207T
• 00190837019457: 36-1411-206T
• 00190837019440: 36-1411-205T
• 00190837019433: 37-1411-712T
• 00190837019426: 37-1411-711T
• 00190837019419: 37-1411-710T
• 00190837019402: 37-1411-709T
• 00190837019396: 37-1411-708T
• 00190837019389: 37-1411-707T
• 00190837019372: 37-1411-706T
• 00190837019365: 37-1411-705T
• 00190837019358: 36-1411-12T
• 00190837019341: 36-1411-11T
• 00190837019334: 36-1411-10T
• 00190837019327: 36-1411-09T
• 00190837019310: 36-1411-08T
• 00190837019303: 36-1411-07T
• 00190837019297: 36-1411-06T
• 00190837019280: 36-1411-05T
• 00190837068646: Cervical Tamp
• 00190837068639: 16x13 Rasp / Trial 12mm, 7 Degree, w/Stop