FDA.reportPublic FDA data

Orthex External Fixation System

Primary DI
00840194428002
Brand
Orthex External Fixation System
Company
ORTHOPEDIATRICS CORP.
Model
ORTHEXSW
Catalog number
ORTHEXSW
Device description
Orthex P&C Software v2
Published
2023-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K223786000
K243798000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223786000Orthex External Fixation SystemOrthoPediatrics Corp.2023-02-10KTT
K243798000Orthex External Fixation SystemOrthoPediatrics Corp.2025-03-07KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194428002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194428002008401944280028401944280020840194428002

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
796416191
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840194405980Pediatric Nailing Platform Femur01-1501-052001-1501-05202022-09-16
00840194405997Pediatric Nailing Platform Femur01-1503-005501-1503-00552022-09-16
00840194406000Pediatric Nailing Platform Femur01-1503-005601-1503-00562022-09-16
00840194407687Pediatric Nailing Platform Femur01-1501-010201-1501-01022022-09-16
00840194407700Pediatric Nailing Platform Femur01-1503-005701-1503-00572022-09-16
00840194407717Pediatric Nailing Platform Femur01-1503-005801-1503-00582022-09-16
00840194407724Pediatric Nailing Platform Femur01-1503-005901-1503-00592022-09-16
00840194407748Pediatric Nailing Platform Femur01-1501-052101-1501-05212022-09-16
00840194417280Pediatric Nailing Platform Femur01-1501-015001-1501-01502022-09-16
00840194417297Pediatric Nailing Platform Femur01-1501-015101-1501-01512022-09-16
00840194417303Pediatric Nailing Platform Femur01-1501-015201-1501-01522022-09-16
00840194417310Pediatric Nailing Platform Femur01-1501-052201-1501-05222022-09-16
00840194417327Pediatric Nailing Platform Femur01-1501-052301-1501-05232022-09-16
00840194417334Pediatric Nailing Platform Femur01-1501-052401-1501-05242022-09-16
00840194445986Pediatric Nailing Platform | Tibia01-1510-005001-1510-00502023-09-15
00840194445993Pediatric Nailing Platform | Tibia01-1510-005101-1510-00512023-09-15
00840194462587Pediatric Nailing Platform | Tibia01-1540-000001-1540-00002023-09-15
00840194462594Pediatric Nailing Platform | Tibia01-1540-000101-1540-00012023-09-15
00840194462686Pediatric Nailing Platform | Tibia01-1510-006001-1510-00602023-09-15
00840194462693Pediatric Nailing Platform | Tibia01-1510-006101-1510-00612023-09-15

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