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FDA 510(k)

ARTHRO-SURGIMAT-2000 ECU

K-Number: K990443 · 1999-02-26

ApplicantW.O.M. World of Medicine GmbH
Decision Date1999-02-26
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHRO-SURGIMAT-2000 ECU is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. World of Medicine GmbH. It received FDA 510(k) clearance on 1999-02-26 under 510(k) number K990443. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHRO-SURGIMAT-2000 ECU?

ARTHRO-SURGIMAT-2000 ECU is a medical device that received FDA 510(k) clearance on 1999-02-26. The listed applicant is W.O.M. World of Medicine GmbH. The 510(k) number is K990443.

When did ARTHRO-SURGIMAT-2000 ECU receive FDA 510(k) clearance?

ARTHRO-SURGIMAT-2000 ECU received FDA 510(k) clearance on 1999-02-26, under 510(k) number K990443.

Who is the listed applicant for ARTHRO-SURGIMAT-2000 ECU?

The FDA 510(k) record lists W.O.M. World of Medicine GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTHRO-SURGIMAT-2000 ECU?

The FDA product code for ARTHRO-SURGIMAT-2000 ECU is HRX.

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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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