BIOFIBER SYTURE— 510(k) K122487
Substantially EquivalentTornier, 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
- Product code NWJ
- Device class
- Class 2
- Regulation
- 21 CFR 878.4494
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.