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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 the device name listed in this FDA 510(k) record. The listed applicant is Wishbone Medical, Inc.. It received FDA 510(k) clearance on 2020-09-18 under 510(k) 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. The listed applicant is Wishbone Medical, Inc.. The 510(k) number is K193368.

When did Smart Correction System receive FDA 510(k) clearance?

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

Who is the listed applicant for Smart Correction System?

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 Smart Correction System?

The FDA product code for Smart Correction System is KTT.

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 PinsK213489Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula PlateK203467WishBone Medical Plate and Screw SystemK182704WishBone Guided Growth System

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Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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