Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Wishbone Medical, Inc.. It received FDA 510(k) clearance on 2022-01-27 under 510(k) 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. The listed applicant is Wishbone Medical, Inc.. The 510(k) number is K213489.

When did Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate receive FDA 510(k) clearance?

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 510(k) number K213489.

Who is the listed applicant for Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate?

The FDA 510(k) record lists Wishbone Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05662449A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation Fixation in Ankle FractureCOMPLETED

Other records listing Wishbone Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231461Smart Correction System (HA Half Pins)K230527WishBone Medical Plate and Screw SystemK221366Smart Correction System Rings and Compatible HA-Coated Half PinsK203467WishBone Medical Plate and Screw SystemK193368Smart Correction SystemK182704WishBone Guided Growth System

View all 9 devices →

Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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.

↑