IB3D™ PL Spinal System

GUDID 03613720286455

CAGE B241C16182209 3D PL 16X18DGX22X9MM

MEDICREA INTERNATIONAL

Metallic spinal interbody fusion cage

• Primary Device ID: 03613720286455
• NIH Device Record Key: e0e1d3c9-2993-41c0-99e1-e8f8d89bc6a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IB3D™ PL Spinal System
• Version Model Number: B241C16182209
• Company DUNS: 383228632
• Company Name: MEDICREA INTERNATIONAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03613720286455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241164

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-24
• Device Publish Date: 2025-02-15

On-Brand Devices [IB3D™ PL Spinal System]

• 03613720286462: CAGE B241C17182209 3D PL 17X18DGX22X9MM
• 03613720286455: CAGE B241C16182209 3D PL 16X18DGX22X9MM
• 03613720286448: CAGE B241C15182209 3D PL 15X18DGX22X9MM
• 03613720286431: CAGE B241C14182209 3D PL 14X18DGX22X9MM
• 03613720286424: CAGE B241C13182209 3D PL 13X18DGX22X9MM
• 03613720286417: CAGE B241C12182209 3D PL 12X18DGX22X9MM
• 03613720286400: CAGE B241C11182209 3D PL 11X18DGX22X9MM
• 03613720286394: CAGE B241C10182209 3D PL 10X18DGX22X9MM
• 03613720286387: CAGE B241C17122209 3D PL 17X12DGX22X9MM
• 03613720286370: CAGE B241C16122209 3D PL 16X12DGX22X9MM
• 03613720286363: CAGE B241C15122209 3D PL 15X12DGX22X9MM
• 03613720286356: CAGE B241C14122209 3D PL 14X12DGX22X9MM
• 03613720286349: CAGE B241C13122209 3D PL 13X12DGX22X9MM
• 03613720286332: CAGE B241C12122209 3D PL 12X12DGX22X9MM
• 03613720286325: CAGE B241C11122209 3D PL 11X12DGX22X9MM
• 03613720286318: CAGE B241C10122209 3D PL 10X12DGX22X9MM
• 03613720286301: CAGE B241C09122209 3D PL 9X12DGX22X9MM
• 03613720286295: CAGE B241C17062209 3D PL 17X6DGX22X9MM
• 03613720286288: CAGE B241C16062209 3D PL 16X6DGX22X9MM
• 03613720286271: CAGE B241C15062209 3D PL 15X6DGX22X9MM
• 03613720286264: CAGE B241C14062209 3D PL 14X6DGX22X9MM
• 03613720286257: CAGE B241C13062209 3D PL 13X6DGX22X9MM
• 03613720286240: CAGE B241C12062209 3D PL 12X6DGX22X9MM
• 03613720286233: CAGE B241C11062209 3D PL 11X6DGX22X9MM
• 03613720286226: CAGE B241C10062209 3D PL 10X6DGX22X9MM
• 03613720286219: CAGE B241C09062209 3D PL 9X6DGX22X9MM
• 03613720286202: CAGE B241C08062209 3D PL 8X6DGX22X9MM