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FDA 510(k)

CONTOURS VSP III VOLAR PLATING SYSTEM

K-Number: K101936 · 2010-10-20

ApplicantOrthofix, Inc.
Decision Date2010-10-20
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONTOURS VSP III VOLAR PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 2010-10-20 under 510(k) number K101936. 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 CONTOURS VSP III VOLAR PLATING SYSTEM?

CONTOURS VSP III VOLAR PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2010-10-20. The listed applicant is Orthofix, Inc.. The 510(k) number is K101936.

When did CONTOURS VSP III VOLAR PLATING SYSTEM receive FDA 510(k) clearance?

CONTOURS VSP III VOLAR PLATING SYSTEM received FDA 510(k) clearance on 2010-10-20, under 510(k) number K101936.

Who is the listed applicant for CONTOURS VSP III VOLAR PLATING SYSTEM?

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 CONTOURS VSP III VOLAR PLATING SYSTEM?

The FDA product code for CONTOURS VSP III VOLAR PLATING SYSTEM is HRS.

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Related Devices (Code: 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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