Lumbar Spacer Inserter 120-00

GUDID B114120000

Inserter used for lumbar inter-vertebral body spacer placement

CALVARY SPINE, LLC

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: B114120000
• NIH Device Record Key: 4f73036e-37b5-40d4-bd44-fe4e626b1a0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumbar Spacer Inserter
• Version Model Number: Lumbar Spacer Inserter
• Catalog Number: 120-00
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B114120000 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B114120000]

Moist Heat or Steam Sterilization

[B114120000]

Moist Heat or Steam Sterilization

[B114120000]

Moist Heat or Steam Sterilization

[B114120000]

Moist Heat or Steam Sterilization

[B114120000]

Moist Heat or Steam Sterilization

[B114120000]

Moist Heat or Steam Sterilization

[B114120000]

Moist Heat or Steam Sterilization

[B114120000]

Moist Heat or Steam Sterilization

[B114120000]

Moist Heat or Steam Sterilization

[B114120000]

Moist Heat or Steam Sterilization

[B114120000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-03-01

Devices Manufactured by CALVARY SPINE, LLC

• B11410010 - Calvary Spine Pedicle Screw System: 2020-12-02 Locking Cap
• B114155250 - Calvary Spine Pedicle Screw System: 2020-12-02 Polyaxial Screw 5.5mm Diameter 25 mm length
• B114155300 - Calvary Spine Pedicle Screw System: 2020-12-02 Polyaxial Screw 5.5mm diameter 30mm length
• B114155350 - Calvary Spine Pedicle Screw System: 2020-12-02 Polyaxial Screw 5.5mm Diameter 35mm length
• B114155400 - Calvary Spine Pedicle Screw System: 2020-12-02 Polyaxial Screw 5.5mm 40 mm Length
• B114155450 - Calvary Spine Pedicle Screw System: 2020-12-02 Polyaxial Screw 5.5mm Diameter 45mm length
• B114155500 - Calvary Spine Pedicle Screw System: 2020-12-02 Polyaxial Screw 5.5mm Diameter 50mm length
• B114155550 - Calvary Spine Pedicle Screw System: 2020-12-02 Polyaxial Screw 5.5mm Diameter 55mm length