Lumbar Interbody Spacer 100-11

GUDID B114100110

11mm Lumbar PEEK inter-vertebral body spacer

CALVARY SPINE, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: B114100110
• NIH Device Record Key: a1395f5d-a4eb-4dbc-b3c4-fb76c0926e67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumbar Interbody Spacer
• Version Model Number: 11mm Crescent
• Catalog Number: 100-11
• 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: 11 Millimeter
• Height: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B114100110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082260

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B114100110]

Moist Heat or Steam Sterilization

[B114100110]

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 [Lumbar Interbody Spacer]

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• B114300110: 11mm Lumbar PEEK inter-vertebral body spacer
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• B114300080: 8mm Lumbar PEEK inter-vertebral body spacer
• B114300070: 7mm Lumbar PEEK inter-vertebral body spacer
• B114100150: 15mm Lumbar PEEK inter-vertebral body spacer
• B114100140: 14mm Lumbar PEEK inter-vertebral body spacer
• B114100130: 13mm Lumbar PEEK inter-vertebral body spacer
• B114100120: 12mm Lumbar PEEK inter-vertebral body spacer
• B114100110: 11mm Lumbar PEEK inter-vertebral body spacer
• B114100100: 10mm Lumbar PEEK inter-vertebral body spacer
• B114100090: 9mm Lumbar PEEK inter-vertebral body spacer
• B114100070: 7mm Lumbar PEEK inter-vertebral body spacer