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FDA 510(k)

TRICON M TIBIAL COMPONENT

K-Number: K843242 · 1984-09-26

ApplicantRichards Medical Co., Inc.
Decision Date1984-09-26
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRICON M TIBIAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Richards Medical Co., Inc.. It received FDA 510(k) clearance on 1984-09-26 under 510(k) number K843242. 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 TRICON M TIBIAL COMPONENT?

TRICON M TIBIAL COMPONENT is a medical device that received FDA 510(k) clearance on 1984-09-26. The listed applicant is Richards Medical Co., Inc.. The 510(k) number is K843242.

When did TRICON M TIBIAL COMPONENT receive FDA 510(k) clearance?

TRICON M TIBIAL COMPONENT received FDA 510(k) clearance on 1984-09-26, under 510(k) number K843242.

Who is the listed applicant for TRICON M TIBIAL COMPONENT?

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

What is the FDA product code for TRICON M TIBIAL COMPONENT?

The FDA product code for TRICON M TIBIAL COMPONENT is JWH.

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Other records listing Richards Medical Co., 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.

K896106ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTSK900628MODULAR HIP SYSTEMK896580UNI-POLAR HEADK895241INTRAMEDULLARY HIP SCREWK884824TRICON-M TOTAL KNEE SYSTEMK896204ZIRCONIA CERAMIC HEAD ADD'L SIZES

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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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