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FDA 510(k)

ORTHOFIX TIBIAL NAILING SYSTEM

K-Number: K961027 · 1996-05-08

ApplicantOrthofix, Inc.
Decision Date1996-05-08
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOFIX TIBIAL NAILING 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 1996-05-08 under 510(k) number K961027. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOFIX TIBIAL NAILING SYSTEM?

ORTHOFIX TIBIAL NAILING SYSTEM is a medical device that received FDA 510(k) clearance on 1996-05-08. The listed applicant is Orthofix, Inc.. The 510(k) number is K961027.

When did ORTHOFIX TIBIAL NAILING SYSTEM receive FDA 510(k) clearance?

ORTHOFIX TIBIAL NAILING SYSTEM received FDA 510(k) clearance on 1996-05-08, under 510(k) number K961027.

Who is the listed applicant for ORTHOFIX TIBIAL NAILING 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 ORTHOFIX TIBIAL NAILING SYSTEM?

The FDA product code for ORTHOFIX TIBIAL NAILING SYSTEM is HSB.

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Related Devices (Code: HSB)

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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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