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FDA 510(k)

POROCOAT FREEMAN/SAMUELSON TOTAL KNEE

K-Number: K831441 · 1983-09-01

ApplicantDepuy, Inc.
Decision Date1983-09-01
Product CodeMBV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POROCOAT FREEMAN/SAMUELSON TOTAL KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1983-09-01 under 510(k) number K831441. 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 POROCOAT FREEMAN/SAMUELSON TOTAL KNEE?

POROCOAT FREEMAN/SAMUELSON TOTAL KNEE is a medical device that received FDA 510(k) clearance on 1983-09-01. The listed applicant is Depuy, Inc.. The 510(k) number is K831441.

When did POROCOAT FREEMAN/SAMUELSON TOTAL KNEE receive FDA 510(k) clearance?

POROCOAT FREEMAN/SAMUELSON TOTAL KNEE received FDA 510(k) clearance on 1983-09-01, under 510(k) number K831441.

Who is the listed applicant for POROCOAT FREEMAN/SAMUELSON TOTAL KNEE?

The FDA 510(k) record lists Depuy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POROCOAT FREEMAN/SAMUELSON TOTAL KNEE?

The FDA product code for POROCOAT FREEMAN/SAMUELSON TOTAL KNEE is MBV.

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Other records listing Depuy, Inc. as applicant

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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.K832302MARK I TOTAL KNEE SYS. ARTHROPLASTYAdvanced Biosearch Assn.

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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