WishBone Medical Plate and Screw System
K-Number: K230527 · 2023-03-29
ApplicantWishbone Medical, Inc.
Decision Date2023-03-29
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
WishBone Medical Plate and Screw System is a medical device manufactured by Wishbone Medical, Inc.. It received FDA 510(k) clearance on 2023-03-29 under approval number K230527. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the WishBone Medical Plate and Screw System?
WishBone Medical Plate and Screw System is a medical device that received FDA 510(k) clearance on 2023-03-29. It is manufactured by Wishbone Medical, Inc.. The 510(k) number is K230527.
When was WishBone Medical Plate and Screw System approved by the FDA?
WishBone Medical Plate and Screw System received FDA 510(k) clearance on 2023-03-29, under approval number K230527.
What company makes WishBone Medical Plate and Screw System?
WishBone Medical Plate and Screw System is manufactured by Wishbone Medical, Inc..
What is the FDA product code for WishBone Medical Plate and Screw System?
The FDA product code for WishBone Medical Plate and Screw System is HRS.
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Other Devices by Wishbone Medical, Inc.
K173013WishBone K-Wire System
K180736WishBone Medical Plate and Screw System
K203467WishBone Medical Plate and Screw System
K193368Smart Correction System
K221366Smart Correction System Rings and Compatible HA-Coated Half Pins
K213489Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.