FDA.reportPublic FDA data

Smart Correction

Primary DI
B562C2C20210
Brand
Smart Correction
Company
Wishbone Medical, Inc.
Model
C2C20210
Device description
Click2Correct/ Smart Correction software
Published
2021-05-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OSNSoftware For Diagnosis/Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSNSoftware For Diagnosis/TreatmentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193368000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193368000Smart Correction SystemWishbone Medical, Inc.2020-09-18KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B562C2C20210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation frame web-based calculator softwareAn application software designed to provide algorithms to assist a physician/surgeon in performing calculations to help create a schedule for the regular adjustment of an external orthopaedic fixation frame (framework) to help facilitate optimum bone growth for fracture healing. The software is accessed via an Internet connection utilizing a web browser (e.g., Microsoft® Internet Explorer). This software performs the necessary mathematical calculations and may provide a visual example of the skeletal deformities. It is intended to be used as an aid to the clinical judgement of a physician/surgeon in a clinic or hospital environment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062355158
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B56251300MDG000G10WishBone Plate & Screw System51-300-MDG000G-151-300-MDG000G-12024-01-01
B562TCX27008US02.7mm x 8mm Ti Cortical ScrewTCX27008-USTCX270082019-11-25
B562TCX27010US02.7mm x 10mm Ti Cortical ScrewTCX27010-USTCX270102019-11-25
B562TCX27012US02.7mm x 12mm Ti Cortical ScrewTCX27012-USTCX270122019-11-25
B562TCX27014US02.7mm x 14mm Ti Cortical ScrewTCX27014-USTCX270142019-11-25
B562TCX27016US02.7mm x 16mm Ti Cortical ScrewTCX27016-USTCX270162019-11-25
B562TCX27018US02.7mm x 18mm Ti Cortical ScrewTCX27018-USTCX270182019-11-25
B562TCX27020US02.7mm x 20mm Ti Cortical ScrewTCX27020-USTCX270202019-11-25
B562TCX27022US02.7mm x 22mm Ti Cortical ScrewTCX27022-USTCX270222019-11-25
B562TCX27024US02.7mm x 24mm Ti Cortical ScrewTCX27024-USTCX270242019-11-25
B562TCX27026US02.7mm x 26mm Ti Cortical ScrewTCX27026-USTCX270262019-11-25
B562TCX27028US02.7mm x 28mm Ti Cortical ScrewTCX27028-USTCX270282019-11-25
B562TCX27030US02.7mm x 30mm Ti Cortical ScrewTCX27030-USTCX270302019-11-25
B562TCX27032US02.7mm x 32mm Ti Cortical ScrewTCX27032-USTCX270322019-11-25
B562TCX27034US02.7mm x 34mm Ti Cortical ScrewTCX27034-USTCX270342019-11-25
B562TCX27036US02.7mm x 36mm Ti Cortical ScrewTCX27036-USTCX270362019-11-25
B562TCX27038US02.7mm x 38mm Ti Cortical ScrewTCX27038-USTCX270382019-11-25
B562TCX27040US02.7mm x 40mm Ti Cortical ScrewTCX27040-USTCX270402019-11-25
B562TCX27045US02.7mm x 45mm Ti Cortical ScrewTCX27045-USTCX270452019-11-25
B562TCX27050US02.7mm x 50mm Ti Cortical ScrewTCX27050-USTCX270502019-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888867544571Arthrex®ARTHREX, INC.OSN2026-03-13
10886982346872MAXFRAMESynthes GmbHOSN2025-01-29
10886982338778MAXFRAMESYNTHES (U.S.A.) LPOSN2024-02-05
10886982338570MAXFRAMESYNTHES (U.S.A.) LPOSN2022-04-26
10886982338587MAXFRAMESYNTHES (U.S.A.) LPOSN2022-04-26
10886982338594MAXFRAMESYNTHES (U.S.A.) LPOSN2022-04-26
10886982338600MAXFRAMESYNTHES (U.S.A.) LPOSN2022-04-26
10886982303608NASynthes GmbHOSN2022-02-07
10886982303615NASynthes GmbHOSN2022-02-07
10886982303639NASynthes GmbHOSN2022-02-07
10886982303653NASynthes GmbHOSN2022-02-07
10886982303738NASynthes GmbHOSN2022-02-07
10886982303769NASynthes GmbHOSN2022-02-07
10886982303813NASynthes GmbHOSN2022-02-07
10886982303837NASynthes GmbHOSN2022-02-07
10886982303844NASynthes GmbHOSN2022-02-07
10886982303899NASynthes GmbHOSN2022-02-07
10886982303974NASynthes GmbHOSN2022-02-07
10886982303981NASynthes GmbHOSN2022-02-07
10886982304070NASynthes GmbHOSN2022-02-07
10886982304094NASynthes GmbHOSN2022-02-07
10886982304100NASynthes GmbHOSN2022-02-07
10886982304124NASynthes GmbHOSN2022-02-07
10886982304131NASynthes GmbHOSN2022-02-07
10886982304148NASynthes GmbHOSN2022-02-07
10886982304209NASynthes GmbHOSN2022-02-07
10886982304216NASynthes GmbHOSN2022-02-07
10886982304223NASynthes GmbHOSN2022-02-07
10886982304322NASynthes GmbHOSN2022-02-07
10886982304346NASynthes GmbHOSN2022-02-07