Cortium Universal OCT Spinal Fixation System

GUDID 00814386027922

Rod, titanium alloy, Ø 3.5mm, length 55mm, curved

Ulrich Medical Usa, Inc.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00814386027922
• NIH Device Record Key: b218a94f-8715-4c7f-9d01-f995a4422c43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cortium Universal OCT Spinal Fixation System
• Version Model Number: UU071-60-0055
• Company DUNS: 624083866
• Company Name: Ulrich Medical Usa, Inc.
• 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: 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: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814386027922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230614

FDA Product Code

• NKG: Posterior Cervical Screw System

Sterilization

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

[00814386027922]

Moist Heat or Steam Sterilization

[00814386027922]

Moist Heat or Steam Sterilization

[00814386027922]

Moist Heat or Steam Sterilization

[00814386027922]

Moist Heat or Steam Sterilization

[00814386027922]

Moist Heat or Steam Sterilization

[00814386027922]

Moist Heat or Steam Sterilization

[00814386027922]

Moist Heat or Steam Sterilization

[00814386027922]

Moist Heat or Steam Sterilization

[00814386027922]

Moist Heat or Steam Sterilization

[00814386027922]

Moist Heat or Steam Sterilization

[00814386027922]

Moist Heat or Steam Sterilization

[00814386027922]

Moist Heat or Steam Sterilization

[00814386027922]

Moist Heat or Steam Sterilization

[00814386027922]

Moist Heat or Steam Sterilization

[00814386027922]

Moist Heat or Steam Sterilization

[00814386027922]

Moist Heat or Steam Sterilization

[00814386027922]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-27
• Device Publish Date: 2024-03-19

On-Brand Devices [Cortium Universal OCT Spinal Fixation System]

• 00814386027380: Reduction Screw, Ø 4.0mm, length 36mm, high angulation
• 00814386027373: Reduction Screw, Ø 4.0mm, length 34mm, high angulation
• 00814386027366: Reduction Screw, Ø 4.0mm, length 32mm, high angulation
• 00814386027359: Reduction Screw, Ø 4.0mm, length 30mm, high angulation
• 00814386027342: Reduction Screw, Ø 4.0mm, length 28mm, high angulation
• 00814386027335: Reduction Screw, Ø 4.0mm, length 26mm, high angulation
• 00814386027328: Reduction Screw, Ø 4.0mm, length 24mm, high angulation
• 00814386027311: Reduction Screw, Ø 4.0mm, length 22mm, high angulation
• 00814386027304: Reduction Screw, Ø 4.0mm, length 20mm, high angulation
• 00814386027298: Reduction Screw, Ø 4.0mm, length 18mm, high angulation
• 00814386027281: Reduction Screw, Ø 4.0mm, length 16mm, high angulation
• 00814386027274: Reduction Screw, Ø 4.0mm, length 14mm, high angulation
• 00814386027267: Reduction Screw, Ø 4.0mm, length 12mm, high angulation
• 00814386027250: Reduction Screw, Ø 4.0mm, length 10mm, high angulation
• 00814386027243: Reduction Screw, Ø 3.5mm, length 40mm, high angulation
• 00814386027236: Reduction Screw, Ø 3.5mm, length 38mm, high angulation
• 00814386027229: Reduction Screw, Ø 3.5mm, length 36mm, high angulation
• 00814386027212: Reduction Screw, Ø 3.5mm, length 34mm, high angulation
• 00814386027205: Reduction Screw, Ø 3.5mm, length 32mm, high angulation
• 00814386027199: Reduction Screw, Ø 3.5mm, length 30mm, high angulation
• 00814386027182: Reduction Screw, Ø 3.5mm, length 28mm, high angulation
• 00814386027175: Reduction Screw, Ø 3.5mm, length 26mm, high angulation
• 00814386027168: Reduction Screw, Ø 3.5mm, length 24mm, high angulation
• 00814386027151: Reduction Screw, Ø 3.5mm, length 22mm, high angulation
• 00814386027144: Reduction Screw, Ø 3.5mm, length 20mm, high angulation
• 00814386027137: Reduction Screw, Ø 3.5mm, length 18mm, high angulation
• 00814386027120: Reduction Screw, Ø 3.5mm, length 16mm, high angulation
• 00814386027113: Reduction Screw, Ø 3.5mm, length 14mm, high angulation
• 00814386027106: Reduction Screw, Ø 3.5mm, length 12mm, high angulation
• 00814386027090: Reduction Screw, Ø 3.5mm, length 10mm, high angulation
• 00814386027083: Thoracic Screw, Ø 5.5mm, length 55mm, high angulation, cannulated, dual lead
• 00814386027076: Thoracic Screw, Ø 5.5mm, length 50mm, high angulation, cannulated, dual lead
• 00814386027069: Thoracic Screw, Ø 5.5mm, length 45mm, high angulation, cannulated, dual lead
• 00814386027052: Thoracic Screw, Ø 5.5mm, length 40mm, high angulation, cannulated, dual lead
• 00814386027045: Thoracic Screw, Ø 5.5mm, length 35mm, high angulation, cannulated, dual lead
• 00814386027038: Thoracic Screw, Ø 5.5mm, length 30mm, high angulation, cannulated, dual lead
• 00814386027021: Thoracic Screw, Ø 5.5mm, length 25mm, high angulation, cannulated, dual lead
• 00814386027014: Thoracic Screw, Ø 4.5mm, length 55mm, high angulation, cannulated, dual lead
• 00814386027007: Thoracic Screw, Ø 4.5mm, length 50mm, high angulation, cannulated, dual lead
• 00814386026994: Thoracic Screw, Ø 4.5mm, length 45mm, high angulation, cannulated, dual lead
• 00814386026987: Thoracic Screw, Ø 4.5mm, length 40mm, high angulation, cannulated, dual lead
• 00814386026970: Thoracic Screw, Ø 4.5mm, length 35mm, high angulation, cannulated, dual lead
• 00814386026963: Thoracic Screw, Ø 4.5mm, length 30mm, high angulation, cannulated, dual lead
• 00814386026956: Thoracic Screw, Ø 4.5mm, length 25mm, high angulation, cannulated, dual lead
• 00814386026949: Thoracic Screw, Ø 5.5mm, length 55mm, high angulation, dual lead
• 00814386026932: Thoracic Screw, Ø 5.5mm, length 50mm, high angulation, dual lead
• 00814386026925: Thoracic Screw, Ø 5.5mm, length 45mm, high angulation, dual lead
• 00814386026918: Thoracic Screw, Ø 5.5mm, length 40mm, high angulation, dual lead
• 00814386026901: Thoracic Screw, Ø 5.5mm, length 35mm, high angulation, dual lead
• 00814386026895: Thoracic Screw, Ø 5.5mm, length 30mm, high angulation, dual lead