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FDA 510(k)

M2A/C2A ACETABULAR SYSTEM

K-Number: K042841 · 2004-12-21

ApplicantBiomet, Inc.
Decision Date2004-12-21
Product CodeJDL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M2A/C2A ACETABULAR 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 2004-12-21 under 510(k) number K042841. 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 M2A/C2A ACETABULAR SYSTEM?

M2A/C2A ACETABULAR SYSTEM is a medical device that received FDA 510(k) clearance on 2004-12-21. The listed applicant is Biomet, Inc.. The 510(k) number is K042841.

When did M2A/C2A ACETABULAR SYSTEM receive FDA 510(k) clearance?

M2A/C2A ACETABULAR SYSTEM received FDA 510(k) clearance on 2004-12-21, under 510(k) number K042841.

Who is the listed applicant for M2A/C2A ACETABULAR 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 M2A/C2A ACETABULAR SYSTEM?

The FDA product code for M2A/C2A ACETABULAR SYSTEM is JDL.

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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 HEADWrightmedicaltechnologyincK041586PROFEMUR S HIP STEMWrightmedicaltechnologyinc

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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