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FDA 510(k)

PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING

K-Number: K022094 · 2002-07-25

ApplicantBiomet, Inc.
Decision Date2002-07-25
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2002-07-25 under 510(k) number K022094. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING?

PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING is a medical device that received FDA 510(k) clearance on 2002-07-25. The listed applicant is Biomet, Inc.. The 510(k) number is K022094.

When did PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING receive FDA 510(k) clearance?

PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING received FDA 510(k) clearance on 2002-07-25, under 510(k) number K022094.

Who is the listed applicant for PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING?

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 PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING?

The FDA product code for PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING is JDI.

Related Clinical Trials

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.

Other records listing Biomet, 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.

View all 418 devices →

Related Devices (Code: JDI)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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