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FDA 510(k)

RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM

K-Number: K110965 · 2011-05-11

ApplicantRenovis Surgical Technologies, LLC
Decision Date2011-05-11
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RENOVIS T 710 LARGE EXTERNAL FIXATION 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 2011-05-11 under 510(k) number K110965. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM?

RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-05-11. The listed applicant is Renovis Surgical Technologies, LLC. The 510(k) number is K110965.

When did RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM receive FDA 510(k) clearance?

RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance on 2011-05-11, under 510(k) number K110965.

Who is the listed applicant for RENOVIS T 710 LARGE EXTERNAL FIXATION 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 T 710 LARGE EXTERNAL FIXATION SYSTEM?

The FDA product code for RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM is KTT.

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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) SYSTEMK120038A200 KNEE SYSTEMK112897RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESISK111940S 100 PEDICLE SCREW SYSTEMK113084RENOVIS CANNULATED SCREW SYSTEM

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Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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