TiBrid™-SA

GUDID 00843511112103

Self-Tapping Variable Screw, Ø5.5x30mm

OMNIA MEDICAL, LLC

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 00843511112103
• NIH Device Record Key: bdba4fd8-edaa-46cb-8ee8-90b6910eec64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiBrid™-SA
• Version Model Number: 17-0A-5530-TV
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Dimensions

• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843511112103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203207

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-07-21
• Device Publish Date: 2023-01-31

On-Brand Devices [TiBrid™-SA]

• 00843511113131: TiBrid™-SA SCREW COVER, 18mm
• 00843511113124: TiBrid™-SA SCREW COVER, 16mm
• 00843511113117: TiBrid™-SA SCREW COVER, 14mm
• 00843511111816: TiBrid™-SA SCREW COVER, 12mm
• 00843511111809: TiBrid™-SA SCREW COVER, 10mm
• 00843511112264: Self-Tapping Fixed Screw, Ø6.0x35mm
• 00843511112257: Self-Tapping Fixed Screw, Ø6.0x30mm
• 00843511112240: Self-Tapping Fixed Screw, Ø6.0x25mm
• 00843511112233: Self-Tapping Fixed Screw, Ø6.0x20mm
• 00843511112226: Self-Tapping Fixed Screw, Ø6.0x15mm
• 00843511112219: Self-Tapping Fixed Screw, Ø5.5x35mm
• 00843511112202: Self-Tapping Fixed Screw, Ø5.5x30mm
• 00843511112196: Self-Tapping Fixed Screw, Ø5.5x25mm
• 00843511112189: Self-Tapping Fixed Screw, Ø5.5x20mm
• 00843511112172: Self-Tapping Fixed Screw, Ø5.5x15mm
• 00843511112165: Self-Tapping Variable Screw, Ø6.0x35mm
• 00843511112158: Self-Tapping Variable Screw, Ø6.0x30mm
• 00843511112141: Self-Tapping Variable Screw, Ø6.0x25mm
• 00843511112134: Self-Tapping Variable Screw, Ø6.0x20mm
• 00843511112127: Self-Tapping Variable Screw, Ø6.0x15mm
• 00843511112110: Self-Tapping Variable Screw, Ø5.5x35mm
• 00843511112103: Self-Tapping Variable Screw, Ø5.5x30mm
• 00843511112097: Self-Tapping Variable Screw, Ø5.5x25mm
• 00843511112080: Self-Tapping Variable Screw, Ø5.5x20mm
• 00843511112073: Self-Tapping Variable Screw, Ø5.5x15mm
• 00843511112066: Self-Drilling Fixed Screw, Ø6.0x35mm
• 00843511112059: Self-Drilling Fixed Screw, Ø6.0x30mm
• 00843511112042: Self-Drilling Fixed Screw, Ø6.0x25mm
• 00843511112035: Self-Drilling Fixed Screw, Ø6.0x20mm
• 00843511112028: Self-Drilling Fixed Screw, Ø6.0x15mm
• 00843511112011: Self-Drilling Fixed Screw, Ø5.5x35mm
• 00843511112004: Self-Drilling Fixed Screw, Ø5.5x30mm
• 00843511111991: Self-Drilling Fixed Screw, Ø5.5x25mm
• 00843511111984: Self-Drilling Fixed Screw, Ø5.5x20mm
• 00843511111977: Self-Drilling Fixed Screw, Ø5.5x15mm
• 00843511111960: Self-Drilling Variable Screw, Ø6.0x35mm
• 00843511111953: Self-Drilling Variable Screw, Ø6.0x30mm
• 00843511111946: Self-Drilling Variable Screw, Ø6.0x25mm
• 00843511111939: Self-Drilling Variable Screw, Ø6.0x20mm
• 00843511111922: Self-Drilling Variable Screw, Ø6.0x15mm
• 00843511111915: Self-Drilling Variable Screw, Ø5.5x35mm
• 00843511111908: Self-Drilling Variable Screw, Ø5.5x30mm
• 00843511111892: Self-Drilling Variable Screw, Ø5.5x25mm
• 00843511111885: Self-Drilling Variable Screw, Ø5.5x20mm
• 00843511111878: Self-Drilling Variable Screw, Ø5.5x15mm
• 00843511111793: TiBrid™-SA Implant, 40x29x18mm, 20°
• 00843511111786: TiBrid™-SA Implant, 40x29x16mm, 20°
• 00843511111779: TiBrid™-SA Implant, 40x29x14mm, 20°
• 00843511111762: TiBrid™-SA Implant, 40x29x12mm, 20°
• 00843511111755: TiBrid™-SA, 36x27x18mm, 20°