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FDA 510(k)

MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM

K-Number: K880826 · 1988-03-14

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1988-03-14
Product CodeKYK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1988-03-14 under 510(k) number K880826. The device is classified under product code KYK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM?

MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1988-03-14. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K880826.

When did MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM receive FDA 510(k) clearance?

MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM received FDA 510(k) clearance on 1988-03-14, under 510(k) number K880826.

Who is the listed applicant for MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM?

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

What is the FDA product code for MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM?

The FDA product code for MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM is KYK.

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Related Devices (Code: KYK)

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.

K871118MODIFIED TOWNLEY UNICONDYLAR KNEEDepuy, Inc.K851341SYNATOMIC VARIABLE FIT TIBIAL PLATEAUDepuy, 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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