DigiFix Sterile Kit— 510(k) K192465

Substantially Equivalent

Virak Orthopedics, LLC

FDA 510(k) clearance K192465 for DigiFix Sterile Kit, Substantially Equivalent on 2019-10-10. Applicant: Virak Orthopedics, LLC. Device class: 2.

Clearance details

Applicant: Virak Orthopedics, LLC
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2019-09-09
Decision date: 2019-10-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Harrison, NJ, 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.