FDA.reportPublic FDA data

SMART TSF

Primary DI
00885556746370
Brand
SMART TSF
Company
Smith & Nephew, Inc.
Model
71075401
Catalog number
71075401
Device description
SMART TSF.COM
Published
2021-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K210953000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210953000SMART Taylor Spatial FrameSmith & Nephew, Inc.2021-07-29KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556746370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556746370008855567463708855567463700885556746370

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010482280CLEAR-TRAC721012172101212015-10-22
03596010532619NA721071972107192015-08-30
03596010505132SCULPTOR721069772106972015-08-30
03596010505149SCULPTOR721069672106962015-08-30
03596010505170SCULPTOR721069572106952015-08-30
03596010505194SCULPTOR721070072107002015-08-30
00885554016703560P72202351722023512015-08-29
00885556919781Real IntelligenceROB30007ROB300072026-10-13
00885556924327Real IntelligenceROB30801ROB308012026-10-08
03596010445803NA720903072090302015-08-30
03596010470294SAPHYRE720968472096842015-08-30
03596010470331ABLATOR720965972096592015-08-30
03596010470348ABLATOR720965872096582015-08-30
03596010470416ABLATOR720965172096512015-08-30
03596010470577ABLATOR720965072096502015-08-30
03596010470614TAC-S720963272096322015-08-30
03596010448446TWINFIX720910972091092015-08-30
03596010470393ABLATOR720965372096532015-08-30
03596010470423ABLATOR720964972096492015-08-30
03596010510976NA721004072100402015-08-30

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