FDA.reportPublic FDA data

PedFlex Flexible Nailing System

Primary DI
00841132100080
Brand
PedFlex Flexible Nailing System
Company
ORTHOPEDIATRICS CORP.
Model
00-1000-340
Catalog number
00-1000-340
Device description
Ø4.0 MM X 450 MM FLEXIBLE IM NAIL
Published
2025-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPIN, FIXATION, SMOOTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082375000
K201838000
K251362000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082375000ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEMOrthoPediatrics Corp.2008-10-17HTY
K201838000PediFlex Flexible Nail SystemOrthoPediatrics Corp.2021-01-29HTY
K251362000PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.2025-06-24HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132100080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132100080008411321000808411321000800841132100080

GMDN Terms#

Term, Definition table
TermDefinition
Femur intramedullary nailA rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it is not dedicated to extension beyond the joint to an adjacent bone (i.e., not dedicated to arthrodesis/joint fusion). It may be a locked or unlocked model and may include components to assist fixation of more proximal or distal conditions. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
796416191
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
00190776436711MilleniumAvalign Technologies, Inc.HTY2026-10-20
05055662968538Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHTY2026-10-16
09353903004240FO NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-10-12
09353903004257FO NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-10-12
M791TPK1237HTA0Traction Pin KitBIOACCESS INCHTY2026-09-04
M791TPK1253HTA0Traction Pin KitBIOACCESS INCHTY2026-09-04
00840536824974PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536824981PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536824998PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825001PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825018PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825025PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825032PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825049PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825056PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825063PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825070PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825087PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825094PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00190776405960MillenniumAvalign Technologies, Inc.HTY2026-07-28
00190776403928MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403935MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436025MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436032MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436049MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436056MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436063MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436070MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436087MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436094MillenniumAvalign Technologies, Inc.HTY2026-07-22