Atlas FDA

DigiFix Sterile Kit

FDA 510(k) clearance K192465 · decided 2019-10-10

Clearance details

K-number
K192465
Device name
DigiFix Sterile Kit
Applicant
Virak Orthopedics, LLC
Decision
Substantially Equivalent
Date received
2019-09-09
Decision date
2019-10-10
Days to decision
31 days
Clearance type
Special
Product code
JEC
Device class
2
Regulation number
888.3040
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Harrison, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.