510(k) K203467

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

K203467 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 December 23, 2020. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Wishbone Medical, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2020
Date Received
November 25, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type