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FDA 510(k)

RMC KNEE METAL SHOE TIBIAL COMPONENTS

K-Number: K792619 · 1980-02-05

ApplicantRichard'S Medical Equip., Inc.
Decision Date1980-02-05
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RMC KNEE METAL SHOE TIBIAL COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Richard'S Medical Equip., Inc.. It received FDA 510(k) clearance on 1980-02-05 under 510(k) number K792619. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RMC KNEE METAL SHOE TIBIAL COMPONENTS?

RMC KNEE METAL SHOE TIBIAL COMPONENTS is a medical device that received FDA 510(k) clearance on 1980-02-05. The listed applicant is Richard'S Medical Equip., Inc.. The 510(k) number is K792619.

When did RMC KNEE METAL SHOE TIBIAL COMPONENTS receive FDA 510(k) clearance?

RMC KNEE METAL SHOE TIBIAL COMPONENTS received FDA 510(k) clearance on 1980-02-05, under 510(k) number K792619.

Who is the listed applicant for RMC KNEE METAL SHOE TIBIAL COMPONENTS?

The FDA 510(k) record lists Richard'S Medical Equip., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RMC KNEE METAL SHOE TIBIAL COMPONENTS?

The FDA product code for RMC KNEE METAL SHOE TIBIAL COMPONENTS is HRY.

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Other records listing Richard'S Medical Equip., 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.

K830793PATIENT GUIDED ELBOW & SHOULDER EXERCK823837RMC TOTAL KNEE SYSTEMK823723SPECTRON PROXIMAL FEMORAL PROSTHESISK823724SPECTRON NECK REPLACEMENT PROSTHESISK823726SPECTRON CONVERSION ENDOPROSTHESIS CUPK823722SPECTRON LONG, STRAIGHT FEMORAL PROSTHES

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Related Devices (Code: HRY)

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.

K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UCK190633NanoOrtho NanoKnee® SystemNanoortho, LLCK152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.K131167UNIVATIONAesculap Implant Systems, LLCK122277OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEMBiomet Manufacturing CorpK110415SIGNATURE PLANNER / SIGNATURE GUIDESMaterialise NV

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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