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FDA 510(k)

A200 KNEE SYSTEM

K-Number: K120038 · 2013-02-14

ApplicantRenovis Surgical Technologies, LLC
Decision Date2013-02-14
Product CodeOIY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

A200 KNEE SYSTEM 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 2013-02-14 under 510(k) number K120038. The device is classified under product code OIY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A200 KNEE SYSTEM?

A200 KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-14. The listed applicant is Renovis Surgical Technologies, LLC. The 510(k) number is K120038.

When did A200 KNEE SYSTEM receive FDA 510(k) clearance?

A200 KNEE SYSTEM received FDA 510(k) clearance on 2013-02-14, under 510(k) number K120038.

Who is the listed applicant for A200 KNEE SYSTEM?

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 A200 KNEE SYSTEM?

The FDA product code for A200 KNEE SYSTEM is OIY.

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Other records listing Renovis Surgical Technologies, LLC 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.

K131354RENOVIS BIPOLAR HIP SYSTEMK131122S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMK112897RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESISK111940S 100 PEDICLE SCREW SYSTEMK113084RENOVIS CANNULATED SCREW SYSTEMK110965RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM

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Related Devices (Code: OIY)

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.

K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc.K242665DePuy ATTUNE™ Total Knee SystemDepuy Orthopedics, Inc.K201347DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc.K121727MOVATION KNEE SYSTEMEncore Medical L.P.K113756HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PAEncore Medical L.P.K111433DEPUY STTUNE (TM) PS KNEE SYSTEMDePuy Orthopaedics, 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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