Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

S128 Anterior Lumbar Interbody Fusion (ALIF) System

K-Number: K180502 · 2018-06-14

ApplicantRenovis Surgical Technologies, Inc.
Decision Date2018-06-14
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

S128 Anterior Lumbar Interbody Fusion (ALIF) System is a medical device manufactured by Renovis Surgical Technologies, Inc.. It received FDA 510(k) clearance on 2018-06-14 under approval number K180502. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S128 Anterior Lumbar Interbody Fusion (ALIF) System?

S128 Anterior Lumbar Interbody Fusion (ALIF) System is a medical device that received FDA 510(k) clearance on 2018-06-14. It is manufactured by Renovis Surgical Technologies, Inc.. The 510(k) number is K180502.

When was S128 Anterior Lumbar Interbody Fusion (ALIF) System approved by the FDA?

S128 Anterior Lumbar Interbody Fusion (ALIF) System received FDA 510(k) clearance on 2018-06-14, under approval number K180502.

What company makes S128 Anterior Lumbar Interbody Fusion (ALIF) System?

S128 Anterior Lumbar Interbody Fusion (ALIF) System is manufactured by Renovis Surgical Technologies, Inc..

What is the FDA product code for S128 Anterior Lumbar Interbody Fusion (ALIF) System?

The FDA product code for S128 Anterior Lumbar Interbody Fusion (ALIF) System is OVD.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes 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 NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED

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: 38273730 Ten-Year Risk of Recall of Novel Spine Devices. Spine (2024)

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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.

↑