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FDA 510(k)

RADIOGRAPHIC MARKERS

K-Number: K011856 · 2001-08-22

ApplicantEncore Orthopedics, Inc.
Decision Date2001-08-22
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RADIOGRAPHIC MARKERS is the device name listed in this FDA 510(k) record. The listed applicant is Encore Orthopedics, Inc.. It received FDA 510(k) clearance on 2001-08-22 under 510(k) number K011856. 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 RADIOGRAPHIC MARKERS?

RADIOGRAPHIC MARKERS is a medical device that received FDA 510(k) clearance on 2001-08-22. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K011856.

When did RADIOGRAPHIC MARKERS receive FDA 510(k) clearance?

RADIOGRAPHIC MARKERS received FDA 510(k) clearance on 2001-08-22, under 510(k) number K011856.

Who is the listed applicant for RADIOGRAPHIC MARKERS?

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

What is the FDA product code for RADIOGRAPHIC MARKERS?

The FDA product code for RADIOGRAPHIC MARKERS 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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