FDA.reportPublic FDA data

510(k) K190365

Device
Baby Gorilla/Gorilla Plating System
Applicant
Paragon 28, Inc.
510(k) number
K190365
Product code
HRS  
Decision
Substantially Equivalent (SESE)
Decision date
2019-04-12
Date received
2019-02-15
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Eric Lintula
Address
4b Inverness Ct. E, Suite 280 Englewood CO US 80112 80112

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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