Omnia Medical TiBrid™-C 07-5C-LT11

GUDID 00843511102012

LORDOTIC TRIAL, 11mm

OMNIA MEDICAL, LLC

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: 00843511102012
• NIH Device Record Key: 26d207c5-40a0-4b68-b897-07799fbbb5d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnia Medical TiBrid™-C
• Version Model Number: 07-5C-LT11
• Catalog Number: 07-5C-LT11
• Company DUNS: 079467378
• Company Name: OMNIA MEDICAL, 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: 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: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com

Device Dimensions

• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843511102012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190363

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[00843511102012]

Moist Heat or Steam Sterilization

[00843511102012]

Moist Heat or Steam Sterilization

[00843511102012]

Moist Heat or Steam Sterilization

[00843511102012]

Moist Heat or Steam Sterilization

[00843511102012]

Moist Heat or Steam Sterilization

[00843511102012]

Moist Heat or Steam Sterilization

[00843511102012]

Moist Heat or Steam Sterilization

[00843511102012]

Moist Heat or Steam Sterilization

[00843511102012]

Moist Heat or Steam Sterilization

[00843511102012]

Moist Heat or Steam Sterilization

[00843511102012]

Moist Heat or Steam Sterilization

[00843511102012]

Moist Heat or Steam Sterilization

[00843511102012]

Moist Heat or Steam Sterilization

[00843511102012]

Moist Heat or Steam Sterilization

[00843511102012]

Moist Heat or Steam Sterilization

[00843511102012]

Moist Heat or Steam Sterilization

[00843511102012]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-20
• Device Publish Date: 2024-03-12

On-Brand Devices [Omnia Medical TiBrid™-C]

• 00843511101695: 14x12x12mm Lordotic cage
• 00843511101688: 14x12x11mm Lordotic cage
• 00843511101671: 14x12x10mm Lordotic cage
• 00843511101664: 14x12x9mm Lordotic cage
• 00843511101657: 14x12x8mm Lordotic cage
• 00843511101640: 14x12x7mm Lordotic cage
• 00843511101633: 14x12x6mm Lordotic cage
• 00843511101626: 14x12x5mm Lordotic cage
• 00843511101459: TiBrid™-C 14x12x12mm Convex cage
• 00843511101435: TiBrid™-C 14x12x10mm Convex cage
• 00843511101428: TiBrid™-C 14x12x9mm Convex cage
• 00843511101411: TiBrid™-C 14x12x8mm Convex cage
• 00843511101404: TiBrid™-C 14x12x7mm Convex cage
• 00843511101398: TiBrid™-C 14x12x6mm Convex cage
• 00843511101381: TiBrid™-C 14x12x5mm Convex cage
• 00843511101855: 18x15x12mm Lordotic cage
• 00843511101848: 18x15x11mm Lordotic cage
• 00843511101831: 18x15x10mm Lordotic cage
• 00843511101824: 18x15x9mm Lordotic cage
• 00843511101817: 18x15x8mm Lordotic cage
• 00843511101800: 18x15x7mm Lordotic cage
• 00843511101794: 18x15x6mm Lordotic cage
• 00843511101787: 18x15x5mm Lordotic cage
• 00843511101770: 16x13.5x12mm Lordotic cage
• 00843511101763: 16x13.5x11mm Lordotic cage
• 00843511101756: 16x13.5x10mm Lordotic cage
• 00843511101749: 16x13.5x9mm Lordotic cage
• 00843511101732: 16x13.5x8mm Lordotic cage
• 00843511101725: 16x13.5x7mm Lordotic cage
• 00843511101718: 16x13.5x6mm Lordotic cage
• 00843511101701: 16x13.5x5mm Lordotic cage
• 00843511101619: 18x15x12mm Convex cage
• 00843511101602: 18x15x11mm Convex cage
• 00843511101596: 18x15x10mm Convex cage
• 00843511101589: 18x15x9mm Convex cage
• 00843511101572: 18x15x8mm Convex cage
• 00843511101565: 18x15x7mm Convex cage
• 00843511101558: 18x15x6mm Convex cage
• 00843511101541: 18x15x5mm Convex cage
• 00843511101534: 16x13.5x12mm Convex cage
• 00843511101527: 16x13.5x11mm Convex cage
• 00843511101510: 16x13.5x10mm Convex cage
• 00843511101503: 16x13.5x9mm Convex cage
• 00843511101497: 16x13.5x8mm Convex cage
• 00843511101480: 16x13.5x7mm Convex cage
• 00843511101473: 16x13.5x6mm Convex cage
• 00843511101466: 16x13.5x5mm Convex cage
• 00843511121884: TiBrid Cervical Tray 2
• 00843511102128: TiBrid Cervical Tray 1
• 00843511102029: LORDOTIC TRIAL, 12mm