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FDA 510(k)

HEALEY REVISION COMPONENT SYSTEM

K-Number: K921139 · 1992-07-01

ApplicantBiomet, Inc.
Decision Date1992-07-01
Product CodeJDL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALEY REVISION COMPONENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1992-07-01 under 510(k) number K921139. The device is classified under product code JDL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALEY REVISION COMPONENT SYSTEM?

HEALEY REVISION COMPONENT SYSTEM is a medical device that received FDA 510(k) clearance on 1992-07-01. The listed applicant is Biomet, Inc.. The 510(k) number is K921139.

When did HEALEY REVISION COMPONENT SYSTEM receive FDA 510(k) clearance?

HEALEY REVISION COMPONENT SYSTEM received FDA 510(k) clearance on 1992-07-01, under 510(k) number K921139.

Who is the listed applicant for HEALEY REVISION COMPONENT SYSTEM?

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

What is the FDA product code for HEALEY REVISION COMPONENT SYSTEM?

The FDA product code for HEALEY REVISION COMPONENT SYSTEM is JDL.

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Other records listing Biomet, Inc. as applicant

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Related Devices (Code: JDL)

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.

K073499VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIESZimmer, Inc.K070785DYNASTY ACETABULAR SYSTEMWrightmedicaltechnologyincK061844DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINERWrightmedicaltechnologyincK051995PROFEMUR RENAISSANCE HIP STEMWrightmedicaltechnologyincK051348CONSERVE TOTAL FEMORAL HEADWrightmedicaltechnologyincK042841M2A/C2A ACETABULAR SYSTEMBiomet, 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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