BIOFIBER SYTURE— 510(k) K122487

Substantially Equivalent

Tornier, Inc.

FDA 510(k) clearance K122487 for BIOFIBER SYTURE, Substantially Equivalent on 2012-09-17. Applicant: Tornier, Inc.. Device class: 2.

Clearance details

Applicant: Tornier, Inc.
Product code: Code NWJ
Device class: Class 2
Regulation: 21 CFR 878.4494
Advisory panel: General, Plastic Surgery
Date received: 2012-08-15
Decision date: 2012-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, MN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.