Republic Spine Restore Intervertebral Body Fusion System
FDA 510(k) K190398 · Republic Spine, LLC
510(k) numberK190398
Submission
- Device name
- Republic Spine Restore Intervertebral Body Fusion System
- Applicant
- Republic Spine, LLC
Boca Raton, FL, US - Received
- February 19, 2019
- Decision date
- September 12, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K223096 | Dark Star Deformity Pedicle Screw SystemNKB · Traditional | 05/26/2023SE |
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| K201420 | Republic Spine Dark Star Spinal SystemNKB · Traditional | 03/05/2021SE |
| K190889 | Republic Spine Restore Cervical Interbody Fusion SystemODP · Traditional | 06/19/2019SE |
| K181495 | Republic Spine Dark Star Spinal SystemNKB · Special | 07/25/2018SE |
| K150283 | Republic Spine Dark Star Spinal SystemMNH · Traditional | 04/29/2015SE |
Questions and answers
When was Republic Spine Restore Intervertebral Body Fusion System cleared by the FDA?
Republic Spine Restore Intervertebral Body Fusion System (K190398) received a 510(k) decision of Substantially Equivalent on September 12, 2019, 205 days after the submission was received.
What is the product code of K190398?
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.