ULTRA-DRIVE 3— 510(k) K031280

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K031280 for ULTRA-DRIVE 3, Substantially Equivalent on 2003-09-22. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code JDX
Device class: Class 2
Regulation: 21 CFR 888.4580
Advisory panel: Orthopedic
Date received: 2003-04-22
Decision date: 2003-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K031280

K-number listed on FDA's recall record

Z-1962-2019 — Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.Class II·Terminated·Zimmer Biomet, Inc.·20190604
Z-1963-2019 — Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.Class II·Terminated·Zimmer Biomet, Inc.·20190604

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031280.

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