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.

Clearance details

Applicant
Virak Orthopedics, LLC
Product code
Code JEC
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Harrison, NJ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.