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FDA 510(k)

TOTAL KNEE SYSTEM

K-Number: K822583 · 1982-10-04

ApplicantRichard'S Medical Equip., Inc.
Decision Date1982-10-04
Product CodeMBV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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 1982-10-04 under 510(k) number K822583. 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 TOTAL KNEE SYSTEM?

TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1982-10-04. The listed applicant is Richard'S Medical Equip., Inc.. The 510(k) number is K822583.

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

TOTAL KNEE SYSTEM received FDA 510(k) clearance on 1982-10-04, under 510(k) number K822583.

Who is the listed applicant for 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 TOTAL KNEE SYSTEM?

The FDA product code for 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 EXERCK823837RMC TOTAL KNEE SYSTEMK823723SPECTRON PROXIMAL FEMORAL PROSTHESISK823726SPECTRON CONVERSION ENDOPROSTHESIS CUPK823724SPECTRON NECK REPLACEMENT PROSTHESISK823722SPECTRON LONG, STRAIGHT 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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