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FDA 510(k)

VOLAR RADIUS PLATE WITH ANGULAR STABILITY

K-Number: K033756 · 2004-02-06

ApplicantI.T.S. Implantat-Technologie-Systeme GmbH
Decision Date2004-02-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VOLAR RADIUS PLATE WITH ANGULAR STABILITY is the device name listed in this FDA 510(k) record. The listed applicant is I.T.S. Implantat-Technologie-Systeme GmbH. It received FDA 510(k) clearance on 2004-02-06 under 510(k) number K033756. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLAR RADIUS PLATE WITH ANGULAR STABILITY?

VOLAR RADIUS PLATE WITH ANGULAR STABILITY is a medical device that received FDA 510(k) clearance on 2004-02-06. The listed applicant is I.T.S. Implantat-Technologie-Systeme GmbH. The 510(k) number is K033756.

When did VOLAR RADIUS PLATE WITH ANGULAR STABILITY receive FDA 510(k) clearance?

VOLAR RADIUS PLATE WITH ANGULAR STABILITY received FDA 510(k) clearance on 2004-02-06, under 510(k) number K033756.

Who is the listed applicant for VOLAR RADIUS PLATE WITH ANGULAR STABILITY?

The FDA 510(k) record lists I.T.S. Implantat-Technologie-Systeme GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VOLAR RADIUS PLATE WITH ANGULAR STABILITY?

The FDA product code for VOLAR RADIUS PLATE WITH ANGULAR STABILITY is HRS.

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Other records listing I.T.S. Implantat-Technologie-Systeme GmbH as applicant

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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