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FDA 510(k)

TRICON REVISION TOTAL KNEE SYSTEM

K-Number: K844706 · 1985-02-19

ApplicantRichards Medical Co., Inc.
Decision Date1985-02-19
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRICON REVISION TOTAL KNEE SYSTEM 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 1985-02-19 under 510(k) number K844706. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRICON REVISION TOTAL KNEE SYSTEM?

TRICON REVISION TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1985-02-19. The listed applicant is Richards Medical Co., Inc.. The 510(k) number is K844706.

When did TRICON REVISION TOTAL KNEE SYSTEM receive FDA 510(k) clearance?

TRICON REVISION TOTAL KNEE SYSTEM received FDA 510(k) clearance on 1985-02-19, under 510(k) number K844706.

Who is the listed applicant for TRICON REVISION TOTAL KNEE SYSTEM?

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 REVISION TOTAL KNEE SYSTEM?

The FDA product code for TRICON REVISION TOTAL KNEE SYSTEM is HSX.

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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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K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer BiometK251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, 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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