FDA.reportPublic FDA data

Orthex

Primary DI
00841132179772
Brand
Orthex
Company
ORTHOPEDIATRICS CORP.
Model
ORTHEXRPS
Catalog number
ORTHEXRPS
Device description
Orthex P&C Software v1.2
Published
2020-02-28
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
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
00841132179772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132179772008411321797728411321797720841132179772

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-use, non-sterileAn assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379bsmith@orthopediatrics.com

Regulatory Flags#

DUNS number
796416191
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841132133200PediFlex01-1000-00101-1000-0012017-02-15
00841132133217PediFlex01-1000-00201-1000-0022017-02-15
00841132135280PediNail21-1500-00721-1500-0072017-02-15
00841132135297PediNail21-1500-01021-1500-0102017-02-15
00841132135303PediNail21-1500-01221-1500-0122017-02-15
00841132135310PediNail21-1500-01321-1500-0132017-02-15
00841132135334PediNail21-1500-01921-1500-0192017-02-15
00841132135341PediNail21-1500-11221-1500-1122017-02-15
00841132135358PediNail21-1500-11921-1500-1192017-02-15
00841132135372PediNail21-1500-911321-1500-91132017-02-15
00841132135389PediNail21-1500-921321-1500-92132017-02-15
00841132135396PediNail21-1500-921421-1500-92142017-02-15
00841132179833Vilex ToolP460-45-100P460-45-1002020-03-02
00841132179888Orthex ToolPP460-15-110PP460-15-1102020-03-02
00841132142325eZ-Fix500-G500-G2020-02-28
00841132142905eZ-Fix900-CW-14900-CW-142020-02-28
00841132142950eZ-Fix900-TW-30900-TW-302020-02-28
00841132143025eZ-Fix925-TW-30925-TW-302020-02-28
00841132125014General Instrument01-1003-300101-1003-30012016-09-25
00841132125021General Instrument01-1003-300201-1003-30022016-09-25

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