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FDA 510(k)

TORNIER, PITON FIXATION IMPLANT SYSTEM

K-Number: K091870 · 2009-09-21

ApplicantTornier
Decision Date2009-09-21
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TORNIER, PITON FIXATION IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tornier. It received FDA 510(k) clearance on 2009-09-21 under 510(k) number K091870. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TORNIER, PITON FIXATION IMPLANT SYSTEM?

TORNIER, PITON FIXATION IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2009-09-21. The listed applicant is Tornier. The 510(k) number is K091870.

When did TORNIER, PITON FIXATION IMPLANT SYSTEM receive FDA 510(k) clearance?

TORNIER, PITON FIXATION IMPLANT SYSTEM received FDA 510(k) clearance on 2009-09-21, under 510(k) number K091870.

Who is the listed applicant for TORNIER, PITON FIXATION IMPLANT SYSTEM?

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

What is the FDA product code for TORNIER, PITON FIXATION IMPLANT SYSTEM?

The FDA product code for TORNIER, PITON FIXATION IMPLANT SYSTEM is MBI.

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Related Devices (Code: MBI)

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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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