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FDA 510(k)

RMC TOTAL KNEE SYSTEM

K-Number: K823837 · 1983-03-29

ApplicantRichard'S Medical Equip., Inc.
Decision Date1983-03-29
Product CodeMBV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RMC TOTAL KNEE SYSTEM 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 1983-03-29 under 510(k) number K823837. The device is classified under product code MBV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RMC TOTAL KNEE SYSTEM?

RMC TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1983-03-29. The listed applicant is Richard'S Medical Equip., Inc.. The 510(k) number is K823837.

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

RMC TOTAL KNEE SYSTEM received FDA 510(k) clearance on 1983-03-29, under 510(k) number K823837.

Who is the listed applicant for RMC TOTAL KNEE SYSTEM?

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 TOTAL KNEE SYSTEM?

The FDA product code for RMC TOTAL KNEE SYSTEM is MBV.

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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 EXERCK823724SPECTRON NECK REPLACEMENT PROSTHESISK823726SPECTRON CONVERSION ENDOPROSTHESIS CUPK823723SPECTRON PROXIMAL FEMORAL PROSTHESISK823722SPECTRON LONG, STRAIGHT FEMORAL PROSTHESK823727SPECTRON PRIMARY STEM FEMORAL PROSTHES

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Related Devices (Code: MBV)

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.

K010212OFFSET TIBIAL TRAYBiomet, Inc.K884824TRICON-M TOTAL KNEE SYSTEMRichards Medical Co., Inc.K873429FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEEProtek, Inc.K853730FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REPProtek, Inc.K833200TRICON M TOTAL KNEE SYSTEMRichards Medical Co., Inc.K831441POROCOAT FREEMAN/SAMUELSON TOTAL KNEEDepuy, 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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