Copperhead

GUDID B014C4009

EMINENT SPINE LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: B014C4009
• NIH Device Record Key: cf4b75ab-f6bd-4284-a322-2cb4a699169b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Copperhead
• Version Model Number: C4009
• Company DUNS: 022576742
• Company Name: EMINENT SPINE LLC
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B014C4009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090064

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

Sterilization

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

[B014C4009]

Moist Heat or Steam Sterilization

[B014C4009]

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: 2017-02-08

On-Brand Devices [Copperhead]

• B014C7112: C7112
• B014C7111: C7111
• B014C7110: C7110
• B014C7109: C7109
• B014C7108: C7108
• B014C7107: C7107
• B014C7106: C7106
• B014C7105: C7105
• B014C7012: C7012
• B014C7011: C7011
• B014C7010: C7010
• B014C7009: C7009
• B014C7008: C7008
• B014C7007: C7007
• B014C7006: C7006
• B014C7005: C7005
• B014C6112: C6112
• B014C6111: C6111
• B014C6110: C6110
• B014C6109: C6109
• B014C6108: C6108
• B014C6107: C6107
• B014C6012: C6012
• B014C6011: C6011
• B014C6010: C6010
• B014C6009: C6009
• B014C6008: C6008
• B014C6007: C6007
• B014C5611: C5611
• B014C5610: C5610
• B014C5609: C5609
• B014C5608: C5608
• B014C5607: C5607
• B014C5606: C5606
• B014C5605: C5605
• B014C5512: C5512
• B014C5511: C5511
• B014C5510: C5510
• B014C5509: C5509
• B014C5508: C5508
• B014C5507: C5507
• B014C5506: C5506
• B014C5111: C5111
• B014C5110: C5110
• B014C5109: C5109
• B014C5108: C5108
• B014C5107: C5107
• B014C5106: C5106
• B014C5011: C5011
• B014C5010: C5010