Lumbar Interbody Spacer Trial 110-08

GUDID B114110080

Trial for 8mm crescent lumbar inter-vertebral body spacer

CALVARY SPINE, LLC

Spinal implant trial

• Primary Device ID: B114110080
• NIH Device Record Key: 9bd1fa84-6472-404c-88ff-e94e1edcb067
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumbar Interbody Spacer Trial
• Version Model Number: 8mm Crescent
• Catalog Number: 110-08
• 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	B114110080 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B114110080]

Moist Heat or Steam Sterilization

[B114110080]

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 [Lumbar Interbody Spacer Trial]

• B114310150: Trial for 15mm straight lumbar inter-vertebral body spacer
• B114310140: Trial for 14mm straight lumbar inter-vertebral body spacer
• B114310130: Trial for 13mm straight lumbar inter-vertebral body spacer
• B114310120: Trial for 12mm straight lumbar inter-vertebral body spacer
• B114310110: Trial for 11mm straight lumbar inter-vertebral body spacer
• B114310100: Trial for 10mm straight lumbar inter-vertebral body spacer
• B114310090: Trial for 9mm straight lumbar inter-vertebral body spacer
• B114310080: Trial for 8mm straight lumbar inter-vertebral body spacer
• B114310070: Trial for 7mm straight lumbar inter-vertebral body spacer
• B114110150: Trial for 15mm crescent lumbar inter-vertebral body spacer
• B114110140: Trial for 14mm crescent lumbar inter-vertebral body spacer
• B114110130: Trial for 13mm crescent lumbar inter-vertebral body spacer
• B114110120: Trial for 12mm crescent lumbar inter-vertebral body spacer
• B114110110: Trial for 11mm crescent lumbar inter-vertebral body spacer
• B114110100: Trial for 10mm crescent lumbar inter-vertebral body spacer
• B114110090: Trial for 9mm crescent lumbar inter-vertebral body spacer
• B114110080: Trial for 8mm crescent lumbar inter-vertebral body spacer
• B114110070: Trial for 7mm crescent lumbar inter-vertebral body spacer