FDA.reportPublic FDA data

510(k) K230527

Device
WishBone Medical Plate and Screw System
Applicant
Wishbone Medical, Inc.
510(k) number
K230527
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-29
Date received
2023-02-27
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
Kayla Johnston
Address
100 Capital Dr. Warsaw IN US 46582 46582

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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