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FDA 510(k)

Smart Correction System Rings and Compatible HA-Coated Half Pins

K-Number: K221366 · 2022-06-06

ApplicantWishbone Medical, Inc.
Decision Date2022-06-06
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Smart Correction System Rings and Compatible HA-Coated Half Pins is a medical device manufactured by Wishbone Medical, Inc.. It received FDA 510(k) clearance on 2022-06-06 under approval number K221366. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smart Correction System Rings and Compatible HA-Coated Half Pins?

Smart Correction System Rings and Compatible HA-Coated Half Pins is a medical device that received FDA 510(k) clearance on 2022-06-06. It is manufactured by Wishbone Medical, Inc.. The 510(k) number is K221366.

When was Smart Correction System Rings and Compatible HA-Coated Half Pins approved by the FDA?

Smart Correction System Rings and Compatible HA-Coated Half Pins received FDA 510(k) clearance on 2022-06-06, under approval number K221366.

What company makes Smart Correction System Rings and Compatible HA-Coated Half Pins?

Smart Correction System Rings and Compatible HA-Coated Half Pins is manufactured by Wishbone Medical, Inc..

What is the FDA product code for Smart Correction System Rings and Compatible HA-Coated Half Pins?

The FDA product code for Smart Correction System Rings and Compatible HA-Coated Half Pins is KTT.

Related Clinical Trials

NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED NCT07033130 The Performance of Different Sound Paths in Adult NeuroZti CI-users TERMINATED NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING NCT07596394 A Registry to Assess the Efficacy and Safety of Transcatheter Treatment for Aortic Valve Disease at the IRCCS Policlinico San Matteo Foundation in Pavia (Italy). RECRUITING NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING

Related PubMed Literature

PMID: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026)

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 K213489Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate K231461Smart Correction System (HA Half Pins)

View all 8 devices →

Related Devices (Code: KTT)

K160972Gexfix External FixationGexfix International Corp. K161753Hoffman LRF SystemStryker GmbH K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC K160830Integra External Fixation SystemAscension Orthopedics K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.

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.

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