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FDA 510(k)

611 ANKLE FUSION NAIL

K-Number: K130051 · 2013-07-15

ApplicantTornier S.A.S.
Decision Date2013-07-15
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

611 ANKLE FUSION NAIL is the device name listed in this FDA 510(k) record. The listed applicant is Tornier S.A.S.. It received FDA 510(k) clearance on 2013-07-15 under 510(k) number K130051. 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 611 ANKLE FUSION NAIL?

611 ANKLE FUSION NAIL is a medical device that received FDA 510(k) clearance on 2013-07-15. The listed applicant is Tornier S.A.S.. The 510(k) number is K130051.

When did 611 ANKLE FUSION NAIL receive FDA 510(k) clearance?

611 ANKLE FUSION NAIL received FDA 510(k) clearance on 2013-07-15, under 510(k) number K130051.

Who is the listed applicant for 611 ANKLE FUSION NAIL?

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

What is the FDA product code for 611 ANKLE FUSION NAIL?

The FDA product code for 611 ANKLE FUSION NAIL 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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