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FDA 510(k)

ICLH TIBIAL PLATEAU

K-Number: K802921 · 1981-01-08

ApplicantDepuy, Inc.
Decision Date1981-01-08
Product CodeMBV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ICLH TIBIAL PLATEAU is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1981-01-08 under 510(k) number K802921. 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 ICLH TIBIAL PLATEAU?

ICLH TIBIAL PLATEAU is a medical device that received FDA 510(k) clearance on 1981-01-08. The listed applicant is Depuy, Inc.. The 510(k) number is K802921.

When did ICLH TIBIAL PLATEAU receive FDA 510(k) clearance?

ICLH TIBIAL PLATEAU received FDA 510(k) clearance on 1981-01-08, under 510(k) number K802921.

Who is the listed applicant for ICLH TIBIAL PLATEAU?

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 ICLH TIBIAL PLATEAU?

The FDA product code for ICLH TIBIAL PLATEAU is MBV.

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Other records listing Depuy, 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.

K043058PINNACLE CONSTRAINED ACETABULAR LINERSK042664LPS UPPER EXTREMITYK041085LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYK033959LPSK040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062K021478DELTA SHOULDER

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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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