IB3D™ PL Spinal System
GUDID 03613720286677
INSERTER A24000000 IB3D IMPLANT
MEDICREA INTERNATIONAL
Orthopaedic inorganic implant inserter/extractor, reusable| Primary Device ID | 03613720286677 |
| NIH Device Record Key | 601a7c8e-44c9-46e3-82f4-460dd3464a23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IB3D™ PL Spinal System |
| Version Model Number | A24000000 |
| Company DUNS | 383228632 |
| Company Name | MEDICREA INTERNATIONAL |
| 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)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03613720286677 [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 | true |
| Device Is Sterile | false |
[03613720286677]
Moist Heat or Steam Sterilization
[03613720286677]
Moist Heat or Steam Sterilization
[03613720286677]
Moist Heat or Steam Sterilization
[03613720286677]
Moist Heat or Steam Sterilization
[03613720286677]
Moist Heat or Steam Sterilization
[03613720286677]
Moist Heat or Steam Sterilization
[03613720286677]
Moist Heat or Steam Sterilization
[03613720286677]
Moist Heat or Steam Sterilization
[03613720286677]
Moist Heat or Steam Sterilization
[03613720286677]
Moist Heat or Steam Sterilization
[03613720286677]
Moist Heat or Steam Sterilization
[03613720286677]
Moist Heat or Steam Sterilization
[03613720286677]
Moist Heat or Steam Sterilization
[03613720286677]
Moist Heat or Steam Sterilization
[03613720286677]
Moist Heat or Steam Sterilization
[03613720286677]
Moist Heat or Steam Sterilization
[03613720286677]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-03 |
| Device Publish Date | 2025-02-21 |
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 |
| 03613720286707 | REMOVER A24000220 IB3D IMPLANT REMOVER |
| 03613720286684 | SLAPHAMMER A24000200 IB3D SLAP HAMMER |
| 03613720286677 | INSERTER A24000000 IB3D IMPLANT |
| 03613720286714 | PUSHER A24000230 IB3D IMPLANT PUSHER |
Trademark Results [IB3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IB3D 98258478 not registered Live/Pending |
Medicrea International 2023-11-07 |
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