Lumbar Trial Spacer Inserter 115-00

GUDID B11411500

Inserter used for trial lumbar inter-vertebral body spacer placement

CALVARY SPINE, LLC

Orthopaedic implant/trial-implant/sizer holder, reusable

• Primary Device ID: B11411500
• NIH Device Record Key: 1466d820-8db3-40f9-8d08-e4f1f7316742
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumbar Trial Spacer Inserter
• Version Model Number: Lumbar Trial Spacer Inserter
• Catalog Number: 115-00
• 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
• Phone: 786-301-8006
• Email: james.r.edw@gmail.com
• Phone: 786-301-8006
• Email: james.r.edw@gmail.com
• Phone: 786-301-8006
• Email: james.r.edw@gmail.com
• Phone: 786-301-8006
• Email: james.r.edw@gmail.com
• Phone: 786-301-8006
• Email: james.r.edw@gmail.com
• Phone: 786-301-8006
• Email: james.r.edw@gmail.com
• Phone: 786-301-8006
• Email: james.r.edw@gmail.com
• Phone: 786-301-8006
• Email: james.r.edw@gmail.com
• Phone: 786-301-8006
• Email: james.r.edw@gmail.com
• Phone: 786-301-8006
• Email: james.r.edw@gmail.com
• Phone: 786-301-8006
• Email: james.r.edw@gmail.com
• Phone: 786-301-8006
• Email: james.r.edw@gmail.com
• Phone: 786-301-8006
• Email: james.r.edw@gmail.com
• Phone: 786-301-8006
• Email: james.r.edw@gmail.com
• Phone: 786-301-8006
• Email: james.r.edw@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B11411500 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B11411500]

Moist Heat or Steam Sterilization

[B11411500]

Moist Heat or Steam Sterilization

[B11411500]

Moist Heat or Steam Sterilization

[B11411500]

Moist Heat or Steam Sterilization

[B11411500]

Moist Heat or Steam Sterilization

[B11411500]

Moist Heat or Steam Sterilization

[B11411500]

Moist Heat or Steam Sterilization

[B11411500]

Moist Heat or Steam Sterilization

[B11411500]

Moist Heat or Steam Sterilization

[B11411500]

Moist Heat or Steam Sterilization

[B11411500]

Moist Heat or Steam Sterilization

[B11411500]

Moist Heat or Steam Sterilization

[B11411500]

Moist Heat or Steam Sterilization

[B11411500]

Moist Heat or Steam Sterilization

[B11411500]

Moist Heat or Steam Sterilization

[B11411500]

Moist Heat or Steam Sterilization

[B11411500]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-03-01

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