FDA.reportPublic FDA data

Pediatric Nailing Platform Femur

Primary DI
00840194415569
Brand
Pediatric Nailing Platform Femur
Company
ORTHOPEDIATRICS CORP.
Model
00-1504-1248
Catalog number
00-1504-1248
Device description
12mm x 480mm Adolescent Nail, Right
Published
2022-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220679000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220679000Pediatric Nailing Platform FemurOrthoPediatrics Corp.2022-07-20HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194415569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194415569008401944155698401944155690840194415569

GMDN Terms#

Term, Definition table
TermDefinition
Femur nailA 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 also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. 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
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
796416191
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841132177570OrthoPediatrics QuickPack Bone Void FillerOPQS1005OPQS10052020-02-11
00841132177587OrthoPediatrics QuickPack Bone Void FillerOPQS1008OPQS10082020-02-11
00841132177594OrthoPediatrics QuickPack Bone Void FillerOPQS1016OPQS10162020-02-11
00841132177600OrthoPediatrics QuickPack Bone Void FillerOPQS0004OPQS00042020-02-11
00840536824288PediHipNS-5001-1711NS-5001-17112026-10-07
00840536824295PediHipNS-5001-1712NS-5001-17122026-10-07
00840536824301PediHipNS-5001-1713NS-5001-17132026-10-07
00840536824318PediHipNS-5001-1714NS-5001-17142026-10-07
00840536824325PediHipNS-5001-1715NS-5001-17152026-10-07
00840536824332PediHipNS-5001-1716NS-5001-17162026-10-07
00840536824349PediHipNS-5001-1721NS-5001-17212026-10-07
00840536824356PediHipNS-5001-1722NS-5001-17222026-10-07
00840536824363PediHipNS-5001-1723NS-5001-17232026-10-07
00840536824370PediHipNS-5001-1724NS-5001-17242026-10-07
00840536824387PediHipNS-5001-1725NS-5001-17252026-10-07
00840536824394PediHipNS-5001-1726NS-5001-17262026-10-07
00817867021044PNP Femur00-1560-716000-1560-71602026-10-01
00817867021051PNP Femur00-1560-716500-1560-71652026-10-01
00817867021068PNP Femur00-1560-717000-1560-71702026-10-01
00817867021075PNP Femur00-1560-717500-1560-71752026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M97012000112300DynaNailMedshape, Inc.HSB2026-10-16
08056693086397ELOS INSTRUMENTSINTRAUMA SPAHSB2026-10-13
08056693086403ELOS INSTRUMENTSINTRAUMA SPAHSB2026-10-13
08056693086410ELOS INSTRUMENTSINTRAUMA SPAHSB2026-10-13
00817867021044PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021051PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021068PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021075PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021082PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021099PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021105PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021112PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021129PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021136PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021143PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021150PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021167PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021174PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021181PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021198PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021204PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021211PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021228PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021235PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021242PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021259PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021266PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021273PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021280PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021297PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01