restor3d TIDAL Lumbar Interbody Fusion System
FDA 510(k) K234087 · Restor3D
510(k) numberK234087
Submission
- Device name
- restor3d TIDAL Lumbar Interbody Fusion System
- Applicant
- Restor3D
Durham, NC, US - Received
- December 22, 2023
- Decision date
- January 22, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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| K242356 | TIDAL Fusion Cage SystemSAI · Traditional | 03/24/2025SE |
| K242868 | Kinos Total Ankle SystemHSN · Special | 10/18/2024SE |
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Questions and answers
When was restor3d TIDAL Lumbar Interbody Fusion System cleared by the FDA?
restor3d TIDAL Lumbar Interbody Fusion System (K234087) received a 510(k) decision of Substantially Equivalent on January 22, 2024, 31 days after the submission was received.
What is the product code of K234087?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.