PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,— 510(k) K123907

Name: FDA 510(k) clearance K123907
Creator: U.S. Food and Drug Administration
Published: 2013-09-03

Substantially Equivalent

Biomet Manufacturing Corp

FDA 510(k) clearance K123907 for PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,, Substantially Equivalent on 2013-09-03. Applicant: Biomet Manufacturing Corp. Device class: 2.

Clearance details

Applicant: Biomet Manufacturing Corp
Product code: Code KRR
Device class: Class 2
Regulation: 21 CFR 888.3540
Advisory panel: Orthopedic
Date received: 2012-12-19
Decision date: 2013-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K123907

K-number listed on FDA's recall record

Z-1318-2016 — All instrumentation associated with the Prelude PF Resurfacing Knee System.Class II·Terminated·Biomet, Inc.·20160309

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123907.

Data sourced from openFDA. This site is unofficial and independent of the FDA.