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FDA 510(k)

TORNIER BIOFIBER SCAFFOLD

K-Number: K102788 · 2011-05-10

ApplicantTornier, Inc.
Decision Date2011-05-10
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TORNIER 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 2011-05-10 under 510(k) number K102788. 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 BIOFIBER SCAFFOLD?

TORNIER BIOFIBER SCAFFOLD is a medical device that received FDA 510(k) clearance on 2011-05-10. The listed applicant is Tornier, Inc.. The 510(k) number is K102788.

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

TORNIER BIOFIBER SCAFFOLD received FDA 510(k) clearance on 2011-05-10, under 510(k) number K102788.

Who is the listed applicant for TORNIER 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 BIOFIBER SCAFFOLD?

The FDA product code for TORNIER BIOFIBER SCAFFOLD is FTL.

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Related Devices (Code: FTL)

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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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