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FDA 510(k)

TORNIER, INC., INSITE SUTURE ANCHORS

K-Number: K083268 · 2009-02-12

ApplicantTornier, Inc.
Decision Date2009-02-12
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TORNIER, INC., INSITE SUTURE ANCHORS is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2009-02-12 under 510(k) number K083268. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TORNIER, INC., INSITE SUTURE ANCHORS?

TORNIER, INC., INSITE SUTURE ANCHORS is a medical device that received FDA 510(k) clearance on 2009-02-12. The listed applicant is Tornier, Inc.. The 510(k) number is K083268.

When did TORNIER, INC., INSITE SUTURE ANCHORS receive FDA 510(k) clearance?

TORNIER, INC., INSITE SUTURE ANCHORS received FDA 510(k) clearance on 2009-02-12, under 510(k) number K083268.

Who is the listed applicant for TORNIER, INC., INSITE SUTURE ANCHORS?

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, INC., INSITE SUTURE ANCHORS?

The FDA product code for TORNIER, INC., INSITE SUTURE ANCHORS is MAI.

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Other records listing Tornier, Inc. as applicant

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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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