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FDA 510(k)

TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES

K-Number: K132632 · 2013-09-19

ApplicantTornier, Inc.
Decision Date2013-09-19
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2013-09-19 under 510(k) number K132632. 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 WITH NEEDLES?

TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES is a medical device that received FDA 510(k) clearance on 2013-09-19. The listed applicant is Tornier, Inc.. The 510(k) number is K132632.

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

TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES received FDA 510(k) clearance on 2013-09-19, under 510(k) number K132632.

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

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 WITH NEEDLES?

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

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Other records listing Tornier, Inc. as applicant

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Related Devices (Code: MBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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