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FDA 510(k)

Renovis Surgical Hip Replacement System

K-Number: K171543 · 2017-11-16

ApplicantRenovis Surgical Technologies
Decision Date2017-11-16
Product CodeOQG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Renovis Surgical Hip Replacement System is a medical device manufactured by Renovis Surgical Technologies. It received FDA 510(k) clearance on 2017-11-16 under approval number K171543. The device is classified under product code OQG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Renovis Surgical Hip Replacement System?

Renovis Surgical Hip Replacement System is a medical device that received FDA 510(k) clearance on 2017-11-16. It is manufactured by Renovis Surgical Technologies. The 510(k) number is K171543.

When was Renovis Surgical Hip Replacement System approved by the FDA?

Renovis Surgical Hip Replacement System received FDA 510(k) clearance on 2017-11-16, under approval number K171543.

What company makes Renovis Surgical Hip Replacement System?

Renovis Surgical Hip Replacement System is manufactured by Renovis Surgical Technologies.

What is the FDA product code for Renovis Surgical Hip Replacement System?

The FDA product code for Renovis Surgical Hip Replacement System is OQG.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT05764954 A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma ACTIVE_NOT_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40902105 Design of Automatic Tool Replacement Mechanism for Laparoscopic Surgical Robot Arm for Solo Surgery. The international journal of medical robotics + computer assisted surgery : MRCAS (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Renovis Surgical Technologies

K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System K170888Renovis S141 Lumbar Interbody Fusion System K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System K181655Renovis S180 Lateral Lumbar Interbody Fusion System K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee System

Related Devices (Code: OQG)

K172651FMP Extended LinersEncore Medical L.P. K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® PolyTotal Joint Orthopedics, Inc. K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc. K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc. K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc. K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.

Official Source

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

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