FDA.reportPublic FDA data

Pediatric Nailing Platform Femur

Primary DI
00840194416580
Brand
Pediatric Nailing Platform Femur
Company
ORTHOPEDIATRICS CORP.
Model
01-1501-0111
Catalog number
01-1501-0111
Device description
PNP Femur Long Reduction Tool
Published
2022-09-16
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
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194416580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194416580008401944165808401944165800840194416580

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone-reduction toolA hand-held manual surgical instrument that is fed down the intramedullary canal of a long bone (e.g., the femur) to help reposition a fracture where the two sections are out of alignment to achieve reduction for consequent reaming and nailing of the bone. It is typically a short cylindrical device with a protruding pointed tip (straight or angled) and which is secured to the distal end of a long, thin, flexible rod/shaft having a handle at the proximal end. It is pressed down the intramedullary canal to the fracture site and the surgeon manipulates the alignment, reducing the bone fragments under image-intensifier control. It is made of high-grade stainless steel. This is a reusable 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841132125014General Instrument01-1003-300101-1003-30012016-09-25
00841132125021General Instrument01-1003-300201-1003-30022016-09-25
00841132125038General Instrument01-1003-300301-1003-30032016-09-25
00841132124277ACL01-1008-253001-1008-25302021-07-06
00841132122112OrthoPediatrics ACL Reconstruction System10-1008-106010-1008-10602015-09-18
00841132122129OrthoPediatrics ACL Reconstruction System10-1008-106510-1008-10652015-09-18
00841132122136OrthoPediatrics ACL Reconstruction System10-1008-107010-1008-10702015-09-18
00841132122143OrthoPediatrics ACL Reconstruction System10-1008-107510-1008-10752015-09-18
00841132122150OrthoPediatrics ACL Reconstruction System10-1008-108010-1008-10802015-09-18
00841132122167OrthoPediatrics ACL Reconstruction System10-1008-108510-1008-10852015-09-18
00841132122174OrthoPediatrics ACL Reconstruction System10-1008-109010-1008-10902015-09-18
00841132122181OrthoPediatrics ACL Reconstruction System10-1008-110010-1008-11002015-09-18
00841132122198OrthoPediatrics ACL Reconstruction System10-1008-406010-1008-40602015-09-18
00841132122204OrthoPediatrics ACL Reconstruction System10-1008-406510-1008-40652015-09-18
00841132122211OrthoPediatrics ACL Reconstruction System10-1008-407010-1008-40702015-09-18
00841132122228OrthoPediatrics ACL Reconstruction System10-1008-407510-1008-40752015-09-18
00841132122235OrthoPediatrics ACL Reconstruction System10-1008-408010-1008-40802015-09-18
00841132122242OrthoPediatrics ACL Reconstruction System10-1008-408510-1008-40852015-09-18
00841132126219General Instrument01-1008-000701-1008-00072016-09-25
00841132126226General Instrument01-1008-001001-1008-00102016-09-25

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