FDA.reportPublic FDA data

PNP Femur

Primary DI
00817867021709
Brand
PNP Femur
Company
ORTHOPEDIATRICS CORP.
Model
00-1560-7490
Catalog number
00-1560-7490
Device description
PNP Retrograde Femur 7mm x 490mm Anatomic Nail, Ti
Published
2026-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
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
K261345000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261345000Pediatric Nailing Platform FemurOrthoPediatrics Corp.2026-09-24HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817867021709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817867021709008178670217098178670217090817867021709

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
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
796416191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
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