Cervical Interbody Spacer 201-08

GUDID B114201080

8mm Cervical PEEK intervertebral body spacer

CALVARY SPINE, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: B114201080
• NIH Device Record Key: aaca0481-e102-46d4-b869-dbb7f9a7463a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cervical Interbody Spacer
• Version Model Number: 8mm Large 14mm x 18mm
• Catalog Number: 201-08
• Company DUNS: 832116532
• Company Name: CALVARY 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: 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	B114201080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082260

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[B114201080]

Moist Heat or Steam Sterilization

[B114201080]

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: 2016-03-01

On-Brand Devices [Cervical Interbody Spacer]

• B114201090: 9mm Cervical PEEK intervertebral body spacer
• B114201080: 8mm Cervical PEEK intervertebral body spacer
• B114201070: 7mm Cervical PEEK intervertebral body spacer
• B114201060: 6mm Cervical PEEK inter-vertebral body spacer
• B114201050: 5mm Cervical PEEK inter-vertebral body spacer
• B114200090: 9mm Cervical PEEK intervertebral body spacer
• B114200080: 8mm Cervical PEEK intervertebral body spacer
• B114200070: 7mm Cervical PEEK intervertebral body spacer
• B114200060: 6mm Cervical PEEK inter-vertebral body spacer
• B114200050: 5mm Cervical PEEK inter-vertebral body spacer