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FDA 510(k)

TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD

K-Number: K111337 · 2012-01-25

ApplicantTornier, Inc.
Decision Date2012-01-25
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2012-01-25 under 510(k) number K111337. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD?

TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD is a medical device that received FDA 510(k) clearance on 2012-01-25. The listed applicant is Tornier, Inc.. The 510(k) number is K111337.

When did TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD receive FDA 510(k) clearance?

TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD received FDA 510(k) clearance on 2012-01-25, under 510(k) number K111337.

Who is the listed applicant for TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD?

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 COLLAGEN COATED BIOFIBER SCAFFOLD?

The FDA product code for TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD is FTL.

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Related Devices (Code: FTL)

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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