Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate
K-Number: K213489 · 2022-01-27
ApplicantWishbone Medical, Inc.
Decision Date2022-01-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate is a medical device manufactured by Wishbone Medical, Inc.. It received FDA 510(k) clearance on 2022-01-27 under approval number K213489. 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: 3.0mm Screws and 7-Hole Straight Fibula Plate?
Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate is a medical device that received FDA 510(k) clearance on 2022-01-27. It is manufactured by Wishbone Medical, Inc.. The 510(k) number is K213489.
When was Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate approved by the FDA?
Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate received FDA 510(k) clearance on 2022-01-27, under approval number K213489.
What company makes Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate?
Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate is manufactured by Wishbone Medical, Inc..
What is the FDA product code for Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate?
The FDA product code for Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate is HRS.
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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.