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FDA 510(k)

PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,

K-Number: K123907 · 2013-09-03

ApplicantBiomet Manufacturing Corp
Decision Date2013-09-03
Product CodeKRR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2013-09-03 under 510(k) number K123907. The device is classified under product code KRR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,?

PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, is a medical device that received FDA 510(k) clearance on 2013-09-03. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K123907.

When did PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, receive FDA 510(k) clearance?

PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, received FDA 510(k) clearance on 2013-09-03, under 510(k) number K123907.

Who is the listed applicant for PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,?

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

What is the FDA product code for PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,?

The FDA product code for PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, is KRR.

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Related Devices (Code: KRR)

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.

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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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