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FDA 510(k)

TORNIER INSITE FT SUTURE ANCHOR

K-Number: K110773 · 2011-06-02

ApplicantTornier, Inc.
Decision Date2011-06-02
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TORNIER INSITE FT SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2011-06-02 under 510(k) number K110773. 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 INSITE FT SUTURE ANCHOR?

TORNIER INSITE FT SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 2011-06-02. The listed applicant is Tornier, Inc.. The 510(k) number is K110773.

When did TORNIER INSITE FT SUTURE ANCHOR receive FDA 510(k) clearance?

TORNIER INSITE FT SUTURE ANCHOR received FDA 510(k) clearance on 2011-06-02, under 510(k) number K110773.

Who is the listed applicant for TORNIER INSITE FT SUTURE ANCHOR?

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

What is the FDA product code for TORNIER INSITE FT SUTURE ANCHOR?

The FDA product code for TORNIER INSITE FT SUTURE ANCHOR is MBI.

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Other records listing Tornier, Inc. as applicant

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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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