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FDA 510(k)

TANTALUM BEADS - RADIOGRAPHIC MARKER

K-Number: K010348 · 2001-05-03

ApplicantBiomet, Inc.
Decision Date2001-05-03
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TANTALUM BEADS - RADIOGRAPHIC MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2001-05-03 under 510(k) number K010348. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANTALUM BEADS - RADIOGRAPHIC MARKER?

TANTALUM BEADS - RADIOGRAPHIC MARKER is a medical device that received FDA 510(k) clearance on 2001-05-03. The listed applicant is Biomet, Inc.. The 510(k) number is K010348.

When did TANTALUM BEADS - RADIOGRAPHIC MARKER receive FDA 510(k) clearance?

TANTALUM BEADS - RADIOGRAPHIC MARKER received FDA 510(k) clearance on 2001-05-03, under 510(k) number K010348.

Who is the listed applicant for TANTALUM BEADS - RADIOGRAPHIC MARKER?

The FDA 510(k) record lists Biomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TANTALUM BEADS - RADIOGRAPHIC MARKER?

The FDA product code for TANTALUM BEADS - RADIOGRAPHIC MARKER is NEU.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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