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FDA 510(k)

TORUS EXTERNAL FIXATION SYSTEM

K-Number: K925635 · 1993-06-01

ApplicantZimmer, Inc.
Decision Date1993-06-01
Product CodeKTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TORUS EXTERNAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1993-06-01 under 510(k) number K925635. The device is classified under product code KTW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TORUS EXTERNAL FIXATION SYSTEM?

TORUS EXTERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1993-06-01. The listed applicant is Zimmer, Inc.. The 510(k) number is K925635.

When did TORUS EXTERNAL FIXATION SYSTEM receive FDA 510(k) clearance?

TORUS EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance on 1993-06-01, under 510(k) number K925635.

Who is the listed applicant for TORUS EXTERNAL FIXATION SYSTEM?

The FDA 510(k) record lists Zimmer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TORUS EXTERNAL FIXATION SYSTEM?

The FDA product code for TORUS EXTERNAL FIXATION SYSTEM is KTW.

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Other records listing Zimmer, Inc. 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.

K262955OsseoFit Stemless Shoulder SystemK260831Z1 Hip SystemK261683Augment Off-Axis Instrument SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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Related Devices (Code: KTW)

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.

K182285PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd.K171606AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos)K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.K160409AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc.K122541ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)Orthofix SrlK080590AOS PROXIMAL HUMERAL PLATEAdvanced Orthopaedic Solutions, 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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