Emerald Cervical PEEK C-L-030

GUDID B104CL0300

5mm Emerald Lordotic Cervical PEEK

GLASIR MEDICAL LP

Polymeric spinal interbody fusion cage

• Primary Device ID: B104CL0300
• NIH Device Record Key: f29b288c-d7b8-407c-8a6a-0f2bdaa82c5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Emerald Cervical PEEK
• Version Model Number: C-L-030
• Catalog Number: C-L-030
• Company DUNS: 066151033
• Company Name: GLASIR MEDICAL LP
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B104CL0300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110659

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[B104CL0300]

Moist Heat or Steam Sterilization

[B104CL0300]

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: 2017-04-05

Devices Manufactured by GLASIR MEDICAL LP

• B104CL0300 - Emerald Cervical PEEK: 2020-02-245mm Emerald Lordotic Cervical PEEK
• B104CL0300 - Emerald Cervical PEEK: 2020-02-24 5mm Emerald Lordotic Cervical PEEK
• B104CL0310 - Emerald Cervical PEEK: 2020-02-24 6mm Emerald Lordotic Cervical PEEK
• B104CL0320 - Emerald Cervical PEEK: 2020-02-24 7mm Emerald Lordotic Cervical PEEK
• B104CL0330 - Emerald Cervical PEEK: 2020-02-24 8mm Emerald Lordotic Cervical PEEK
• B104CL0340 - Emerald Cervical PEEK: 2020-02-24 9mm Emerald Lordotic Cervical PEEK
• B104CL0350 - Emerald Cervical PEEK: 2020-02-24 10mm Emerald Lordotic Cervical PEEK
• B104CL0360 - Emerald Cervical PEEK: 2020-02-24 11mm Emerald Lordotic Cervical PEEK
• B104CL0370 - Emerald Cervical PEEK: 2020-02-24 12mm Emerald Lordotic Cervical PEEK