Prelude PF Patellae— 510(k) K143543

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K143543 for Prelude PF Patellae, Substantially Equivalent on 2015-01-30. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code KRR
Device class: Class 2
Regulation: 21 CFR 888.3540
Advisory panel: Orthopedic
Date received: 2014-12-15
Decision date: 2015-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K143543

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 K143543.

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