510(k) K180736

WishBone Medical Plate and Screw System by Wishbone Medical, Inc. — Product Code HRS

K180736 is an FDA 510(k) premarket notification submitted by Wishbone Medical, Inc. for the device "WishBone Medical Plate and Screw System". The FDA issued a decision of Substantially Equivalent on October 4, 2018. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Wishbone Medical, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2018
Date Received
March 22, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type