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FDA 510(k)

ORTHOFIX VOLAR DISTAL RADIAL PLATE

K-Number: K042766 · 2004-11-16

ApplicantOrthofix, Inc.
Decision Date2004-11-16
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOFIX VOLAR DISTAL RADIAL PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 2004-11-16 under 510(k) number K042766. 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 ORTHOFIX VOLAR DISTAL RADIAL PLATE?

ORTHOFIX VOLAR DISTAL RADIAL PLATE is a medical device that received FDA 510(k) clearance on 2004-11-16. The listed applicant is Orthofix, Inc.. The 510(k) number is K042766.

When did ORTHOFIX VOLAR DISTAL RADIAL PLATE receive FDA 510(k) clearance?

ORTHOFIX VOLAR DISTAL RADIAL PLATE received FDA 510(k) clearance on 2004-11-16, under 510(k) number K042766.

Who is the listed applicant for ORTHOFIX VOLAR DISTAL RADIAL PLATE?

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

What is the FDA product code for ORTHOFIX VOLAR DISTAL RADIAL PLATE?

The FDA product code for ORTHOFIX VOLAR DISTAL RADIAL PLATE is HRS.

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Official Source

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

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