Cervical Interbody Spacer Trial 211-08

GUDID B114211080

Dual Head Trial for 8mm standard and large cervical inter-vertebral body spacers

CALVARY SPINE, LLC

Spinal implant trial

• Primary Device ID: B114211080
• NIH Device Record Key: af497e31-949e-41cb-92d8-3185c6db7e95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cervical Interbody Spacer Trial
• Version Model Number: 8mm Dual Head Trial
• Catalog Number: 211-08
• Company DUNS: 832116532
• Company Name: CALVARY SPINE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: 786-301-8006
• Email: james.r.edw@gmail.com
• Phone: 786-301-8006
• Email: james.r.edw@gmail.com

Device Dimensions

• Height: 8 Millimeter
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B114211080 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B114211080]

Moist Heat or Steam Sterilization

[B114211080]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-03-01

On-Brand Devices [Cervical Interbody Spacer Trial]

• B114211090: Dual Head Trial for 9mm standard and large cervical inter-vertebral body spacers
• B114211080: Dual Head Trial for 8mm standard and large cervical inter-vertebral body spacers
• B114211070: Dual Head Trial for 7mm standard and large cervical inter-vertebral body spacers
• B114211060: Dual Head Trial for 6mm standard and large cervical inter-vertebral body spacers
• B114211050: Dual Head Trial for 5mm standard and large cervical inter-vertebral body spacers
• B114210090: Trial for 9mm standard cervical inter-vertebral body spacer
• B114210080: Trial for 8mm standard cervical inter-vertebral body spacer
• B114210070: Trial for 7mm standard cervical inter-vertebral body spacer
• B114210060: Trial for 6mm standard cervical inter-vertebral body spacer
• B114210050: Trial for 5mm standard cervical inter-vertebral body spacer