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FDA 510(k)

Renovis S180 Lateral Lumbar Interbody Fusion System

K-Number: K181655 · 2018-09-11

ApplicantRenovis Surgical Technologies
Decision Date2018-09-11
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Renovis S180 Lateral Lumbar Interbody Fusion System is a medical device manufactured by Renovis Surgical Technologies. It received FDA 510(k) clearance on 2018-09-11 under approval number K181655. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Renovis S180 Lateral Lumbar Interbody Fusion System?

Renovis S180 Lateral Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2018-09-11. It is manufactured by Renovis Surgical Technologies. The 510(k) number is K181655.

When was Renovis S180 Lateral Lumbar Interbody Fusion System approved by the FDA?

Renovis S180 Lateral Lumbar Interbody Fusion System received FDA 510(k) clearance on 2018-09-11, under approval number K181655.

What company makes Renovis S180 Lateral Lumbar Interbody Fusion System?

Renovis S180 Lateral Lumbar Interbody Fusion System is manufactured by Renovis Surgical Technologies.

What is the FDA product code for Renovis S180 Lateral Lumbar Interbody Fusion System?

The FDA product code for Renovis S180 Lateral Lumbar Interbody Fusion System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Renovis Surgical Technologies

K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System K171543Renovis Surgical Hip Replacement System K170888Renovis S141 Lumbar Interbody Fusion System K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee System

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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