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FDA 510(k)

RENOVIS BIPOLAR HIP SYSTEM

K-Number: K131354 · 2013-09-19

ApplicantRenovis Surgical Technologies, LLC
Decision Date2013-09-19
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RENOVIS BIPOLAR HIP 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 2013-09-19 under 510(k) number K131354. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENOVIS BIPOLAR HIP SYSTEM?

RENOVIS BIPOLAR HIP SYSTEM is a medical device that received FDA 510(k) clearance on 2013-09-19. The listed applicant is Renovis Surgical Technologies, LLC. The 510(k) number is K131354.

When did RENOVIS BIPOLAR HIP SYSTEM receive FDA 510(k) clearance?

RENOVIS BIPOLAR HIP SYSTEM received FDA 510(k) clearance on 2013-09-19, under 510(k) number K131354.

Who is the listed applicant for RENOVIS BIPOLAR HIP 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 RENOVIS BIPOLAR HIP SYSTEM?

The FDA product code for RENOVIS BIPOLAR HIP SYSTEM is KWY.

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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.

K131122S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMK120038A200 KNEE 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: KWY)

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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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