510(k) K234087
- Device
- restor3d TIDAL Lumbar Interbody Fusion System
- Applicant
- Restor3D
- 510(k) number
- K234087
- Product code
- MAX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-01-22
- Date received
- 2023-12-22
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Anika Moorjani
- Address
- 4001 E. Nc 54 Hwy., Suite 3160 Durham NC US 27709 27709
FDA Registration Numbers
- 3015709929
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840097509648 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097505282 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097505299 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097505305 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509532 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509549 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509556 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509563 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509570 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509587 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509594 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509600 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509617 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509624 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509631 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509990 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509655 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509662 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509679 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509686 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509693 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509709 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509716 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509723 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509730 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509952 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509969 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509976 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
| 00840097509983 | restor3d Lumbar Instrumentation | Restor3d, Inc. | 2024-04-17 |
Other 510(k) Records For Product Code MAX
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260506 | Ventana® P/T Lumbar Interbody System | Spinal Elements, Inc. | 2026-05-15 |
| K260837 | VersaLift Expandable System | Life Spine, Inc. | 2026-05-12 |
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system | Carlsmed, Inc. | 2026-05-09 |
| K261067 | BEE PLIF Cage | NGMedical GmbH | 2026-04-30 |
| K254017 | SWINGO-3D Lumbar Cage System | Implanet | 2026-02-26 |
| K253583 | LUX Expandable Lumbar Interbody System | Xenix Medical | 2026-02-23 |
| K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | 2026-02-04 |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | Life Spine, Inc. | 2026-01-23 |
| K253266 | Titanium Interbody System | Spine Innovation, LLC | 2026-01-08 |
| K253577 | IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) | 2025-12-19 |
| K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 2025-11-25 |
| K252351 | UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. | 2025-10-28 |
| K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | 2025-10-24 |
| K251479 | Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) | Mobarn Medical Devices, LLC | 2025-09-18 |
| K251444 | Endoskeleton Interbody Systems | Medtronic Sofamor Danek USA, Inc. | 2025-09-04 |