FDA.reportPublic FDA data

Orthex

Primary DI
00841731119209
Brand
Orthex
Company
VILEX IN TENNESSEE, INC.
Model
ORTHEXRPS
Device description
Orthex P&C Software
Published
2017-06-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
OSNSoftware For Diagnosis/Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2
OSNSoftware For Diagnosis/TreatmentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151881000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151881000X-Fix Line AdditionsVilex IN Tennessee, Inc.2016-03-24KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731119209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731119209008417311192098417311192090841731119209

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
152008371
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841731120274Vilex GuidewireK100-09DK100-09D2018-08-06
00841731120281Vilex GuidewireK100-09GK100-09G2018-08-06
00841731120298Vilex GuidewireK100-09SK100-09S2018-08-06
00841731120304Vilex GuidewireK100-11DK100-11D2018-08-06
00841731120311Vilex GuidewireK100-11PTK100-11PT2018-08-06
00841731120328Vilex GuidewireK100-11SK100-11S2018-08-06
00841731120335Vilex GuidewireK100-12SK100-12S2018-08-06
00841731120342Vilex GuidewireK100-14SK100-14S2018-08-06
00841731120359Vilex GuidewireK100-16DK100-16D2018-08-06
00841731120366Vilex GuidewireK100-16SK100-16S2018-08-06
00841731120373Vilex GuidewireK100-20SK100-20S2018-08-06
00841731120441Vilex Plate GuidewireK11-60TK11-60T2018-08-08
00841731120465Vilex GuidewireK150-09DK150-09D2018-08-08
00841731120472Vilex GuidewireK150-11DK150-11D2018-08-08
00841731120489Vilex GuidewireK150-11PTK150-11PT2018-08-08
00841731120496Vilex GuidewireK150-11SK150-11S2018-08-08
00841731120502Vilex GuidewireK150-12DK150-12D2018-08-08
00841731120519Vilex GuidewireK150-12SK150-12S2018-08-08
00841731120526Vilex GuidewireK150-14DK150-14D2018-08-08
00841731120533Vilex GuidewireK150-14SK150-14S2018-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327616859HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616880HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616835HOFFMANN LRFStryker GmbHKTT2026-07-21
07613327616866HOFFMANN LRFStryker GmbHKTT2026-07-21
00889795154620Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154637Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154644Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154651Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
10888867544571Arthrex®ARTHREX, INC.OSN2026-03-13
10888867544571Arthrex®ARTHREX, INC.KTT2026-03-13
10886982346872MAXFRAMESynthes GmbHKTT2025-01-29
10886982346872MAXFRAMESynthes GmbHOSN2025-01-29
00810028396166EF1Medshape, Inc.KTT2024-07-09
00810028396159EF1Medshape, Inc.KTT2024-05-31
00810028396173EF1Medshape, Inc.KTT2024-05-31
00810028396142EF1Medshape, Inc.KTT2024-05-31
10886982338778MAXFRAMESYNTHES (U.S.A.) LPKTT2024-02-05
10886982338778MAXFRAMESYNTHES (U.S.A.) LPOSN2024-02-05
10886982343710MAXFRAMESynthes GmbHKTT2024-01-04
10886982343727MAXFRAMESynthes GmbHKTT2024-01-04
10886982343734MAXFRAMESynthes GmbHKTT2024-01-04
10886982338570MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338570MAXFRAMESYNTHES (U.S.A.) LPOSN2022-04-26
10886982338587MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338587MAXFRAMESYNTHES (U.S.A.) LPOSN2022-04-26
10886982338594MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338594MAXFRAMESYNTHES (U.S.A.) LPOSN2022-04-26
10886982338600MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338600MAXFRAMESYNTHES (U.S.A.) LPOSN2022-04-26
00841132142325eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28