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FDA 510(k)

TRIATHLON TS KNEE SYSTEM

K-Number: K070095 · 2007-06-01

ApplicantHowmedica Osteonics Corp.
Decision Date2007-06-01
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIATHLON TS KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2007-06-01 under 510(k) number K070095. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIATHLON TS KNEE SYSTEM?

TRIATHLON TS KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2007-06-01. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K070095.

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

TRIATHLON TS KNEE SYSTEM received FDA 510(k) clearance on 2007-06-01, under 510(k) number K070095.

Who is the listed applicant for TRIATHLON TS KNEE SYSTEM?

The FDA 510(k) record lists Howmedica Osteonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIATHLON TS KNEE SYSTEM?

The FDA product code for TRIATHLON TS KNEE SYSTEM is JWH.

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Related Devices (Code: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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