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FDA 510(k)

RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS

K-Number: K112897 · 2012-06-13

ApplicantRenovis Surgical Technologies, LLC
Decision Date2012-06-13
Product CodeOQG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Renovis Surgical Technologies, LLC. It received FDA 510(k) clearance on 2012-06-13 under 510(k) number K112897. 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 JOINT REPLACEMENT PROSTHESIS?

RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS is a medical device that received FDA 510(k) clearance on 2012-06-13. The listed applicant is Renovis Surgical Technologies, LLC. The 510(k) number is K112897.

When did RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS receive FDA 510(k) clearance?

RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS received FDA 510(k) clearance on 2012-06-13, under 510(k) number K112897.

Who is the listed applicant for RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS?

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

What is the FDA product code for RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS?

The FDA product code for RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS is OQG.

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Other records listing Renovis Surgical Technologies, LLC as applicant

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K131354RENOVIS BIPOLAR HIP SYSTEMK131122S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMK120038A200 KNEE SYSTEMK111940S 100 PEDICLE SCREW SYSTEMK113084RENOVIS CANNULATED SCREW SYSTEMK110965RENOVIS T 710 LARGE EXTERNAL FIXATION 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.K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies

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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