Renovis S180 Lateral Lumbar Interbody Fusion System
FDA 510(k) K181655 · Renovis Surgical Technologies
510(k) numberK181655
Submission
- Device name
- Renovis S180 Lateral Lumbar Interbody Fusion System
- Applicant
- Renovis Surgical Technologies
Redlands, CA, US - Received
- June 22, 2018
- Decision date
- September 11, 2018
- 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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| K171543 | Renovis Surgical Hip Replacement SystemOQG · Traditional | 11/16/2017SE |
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| K153250 | Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemOVE · Traditional | 03/16/2016SE |
| K152193 | Renovis Anterior Cervical Plate SystemKWQ · Traditional | 09/25/2015SE |
| K143647 | Renovis Surgical Hip Replacement SystemOQG · Traditional | 05/11/2015SE |
| K143126 | Renovis S141 Lumbar Interbody Cage SystemMAX · Traditional | 02/06/2015SE |
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Questions and answers
When was Renovis S180 Lateral Lumbar Interbody Fusion System cleared by the FDA?
Renovis S180 Lateral Lumbar Interbody Fusion System (K181655) received a 510(k) decision of Substantially Equivalent on September 11, 2018, 81 days after the submission was received.
What is the product code of K181655?
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.