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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 the device name listed in this FDA 510(k) record. The listed applicant is Renovis Surgical Technologies. It received FDA 510(k) clearance on 2017-11-16 under 510(k) 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. The listed applicant is Renovis Surgical Technologies. The 510(k) number is K171543.

When did Renovis Surgical Hip Replacement System receive FDA 510(k) clearance?

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

Who is the listed applicant for Renovis Surgical Hip Replacement System?

The FDA 510(k) record lists Renovis Surgical Technologies as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Renovis Surgical Technologies as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemK182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemK181655Renovis S180 Lateral Lumbar Interbody Fusion SystemK180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemK170888Renovis S141 Lumbar Interbody Fusion SystemK153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System

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Related Devices (Code: OQG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.K203472KMTI Hip Replacement SystemKyocera Medical Technologies, 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.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.

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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