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FDA 510(k)

GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS)

K-Number: K871146 · 1987-07-31

ApplicantRichards Medical Co., Inc.
Decision Date1987-07-31
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS) 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 1987-07-31 under 510(k) number K871146. 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 GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS)?

GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS) is a medical device that received FDA 510(k) clearance on 1987-07-31. The listed applicant is Richards Medical Co., Inc.. The 510(k) number is K871146.

When did GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS) receive FDA 510(k) clearance?

GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS) received FDA 510(k) clearance on 1987-07-31, under 510(k) number K871146.

Who is the listed applicant for GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS)?

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 GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS)?

The FDA product code for GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS) 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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