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FDA 510(k)

THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES

K-Number: K102282 · 2010-12-07

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics
Decision Date2010-12-07
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2010-12-07 under 510(k) number K102282. 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 THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES?

THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES is a medical device that received FDA 510(k) clearance on 2010-12-07. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K102282.

When did THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES receive FDA 510(k) clearance?

THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES received FDA 510(k) clearance on 2010-12-07, under 510(k) number K102282.

Who is the listed applicant for THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES?

The FDA 510(k) record lists Howmedica Osteonics Corp., Dba Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES?

The FDA product code for THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES is HRS.

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Official Source

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