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FDA 510(k)

DURASUL BIPOLAR

K-Number: K040947 · 2004-08-27

ApplicantCenterpulse Orthopedics, Inc.
Decision Date2004-08-27
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DURASUL BIPOLAR is the device name listed in this FDA 510(k) record. The listed applicant is Centerpulse Orthopedics, Inc.. It received FDA 510(k) clearance on 2004-08-27 under 510(k) number K040947. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURASUL BIPOLAR?

DURASUL BIPOLAR is a medical device that received FDA 510(k) clearance on 2004-08-27. The listed applicant is Centerpulse Orthopedics, Inc.. The 510(k) number is K040947.

When did DURASUL BIPOLAR receive FDA 510(k) clearance?

DURASUL BIPOLAR received FDA 510(k) clearance on 2004-08-27, under 510(k) number K040947.

Who is the listed applicant for DURASUL BIPOLAR?

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

What is the FDA product code for DURASUL BIPOLAR?

The FDA product code for DURASUL BIPOLAR is KWY.

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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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