CarboClear Cervical Cage / VBR System PL940340

GUDID 07290110208912

Insertion Handle for use with the CarboClear Cervical Cage

CARBOFIX ORTHOPEDICS LTD

Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: 07290110208912
• NIH Device Record Key: 422bee0c-ea04-4cad-9bd3-bf3676aa77af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarboClear Cervical Cage / VBR System
• Version Model Number: Implant Inserter - Outer Tube, Small
• Catalog Number: PL940340
• Company DUNS: 649185170
• Company Name: CARBOFIX ORTHOPEDICS LTD
• 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: 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: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110208912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222874

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[07290110208912]

Moist Heat or Steam Sterilization

[07290110208912]

Moist Heat or Steam Sterilization

[07290110208912]

Moist Heat or Steam Sterilization

[07290110208912]

Moist Heat or Steam Sterilization

[07290110208912]

Moist Heat or Steam Sterilization

[07290110208912]

Moist Heat or Steam Sterilization

[07290110208912]

Moist Heat or Steam Sterilization

[07290110208912]

Moist Heat or Steam Sterilization

[07290110208912]

Moist Heat or Steam Sterilization

[07290110208912]

Moist Heat or Steam Sterilization

[07290110208912]

Moist Heat or Steam Sterilization

[07290110208912]

Moist Heat or Steam Sterilization

[07290110208912]

Moist Heat or Steam Sterilization

[07290110208912]

Moist Heat or Steam Sterilization

[07290110208912]

Moist Heat or Steam Sterilization

[07290110208912]

Moist Heat or Steam Sterilization

[07290110208912]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-26
• Device Publish Date: 2023-09-18

On-Brand Devices [CarboClear Cervical Cage / VBR System]

• 07290117351260: A surgical tool intended to prepare the endplates of the adjacent vertebrae prior to implant ins
• 07290117351253: A surgical tool used with the Implant Trials, if required, to assist in Trial removal from the d
• 07290110209001: A surgical tool for use with the Cervical Cage / VBR devices. The Implant Trial is intended for
• 07290110208998: A surgical tool for use with the Cervical Cage / VBR devices. The Implant Trial is intended for
• 07290110208981: A surgical tool for use with the Cervical Cage / VBR devices. The Implant Trial is intended for
• 07290110208974: A surgical tool for use with the Cervical Cage / VBR devices. The Implant Trial is intended for
• 07290110208967: A surgical tool for use with the Cervical Cage / VBR devices. The Implant Trial is intended for
• 07290110208950: A surgical tool intended to assist in cage positioning within the disc space when required
• 07290110208943: Insertion Handle for use with the CarboClear Cervical Cage / VBR
• 07290110208936: Insertion Handle for use with the CarboClear Cervical Cage / VBR
• 07290110208929: Insertion Handle for use with the CarboClear Cervical Cage
• 07290110208912: Insertion Handle for use with the CarboClear Cervical Cage