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FDA 510(k)

Smart Correction System

K-Number: K193368 · 2020-09-18

ApplicantWishbone Medical, Inc.
Decision Date2020-09-18
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Smart Correction System is a medical device manufactured by Wishbone Medical, Inc.. It received FDA 510(k) clearance on 2020-09-18 under approval number K193368. 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?

Smart Correction System is a medical device that received FDA 510(k) clearance on 2020-09-18. It is manufactured by Wishbone Medical, Inc.. The 510(k) number is K193368.

When was Smart Correction System approved by the FDA?

Smart Correction System received FDA 510(k) clearance on 2020-09-18, under approval number K193368.

What company makes Smart Correction System?

Smart Correction System is manufactured by Wishbone Medical, Inc..

What is the FDA product code for Smart Correction System?

The FDA product code for Smart Correction System is KTT.

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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 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 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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