510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K010348Substantially Equivalent

Tantalum Beads - Radiographic Marker

Zimmer GmbH, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010348 is the FDA 510(k) clearance record for TANTALUM BEADS - RADIOGRAPHIC MARKER, a class II device, cleared for Biomet, Inc. on under FDA product code NEU (Marker, Radiographic, Implantable). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K010348.

Clearance record

Decision date
Received
(87 days to decision)
Product code
NEU Marker, Radiographic, Implantable
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Biomet, Inc. 56 E Bell Dr., Warsaw IN
510(k) summary
Summary
Third party review
No

Clearances, product code NEU

Trailing 12 months
4 clearances under product code NEU in the twelve months to November 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code NEU, trailing twelve months
MonthClearances
December 20253
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260