Cleared Traditional

K010348 - TANTALUM BEADS - RADIOGRAPHIC MARKER (FDA 510(k) Clearance)

K010348 · Biomet, Inc. · General & Plastic Surgery device

May 2001

Decision

87d

Days

Class 2

Risk

K010348 is an FDA 510(k) clearance for the TANTALUM BEADS - RADIOGRAPHIC MARKER. This device is classified as a Marker, Radiographic, Implantable (Class II - Special Controls, product code NEU).

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 3, 2001, 87 days after receiving the submission on February 5, 2001.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number	K010348 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 05, 2001
Decision Date	May 03, 2001
Days to Decision	87 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF