Pediatric Nailing Platform Femur 00-1506-6023

GUDID 00840194416276

4.0mm x 22.5mm Fully Threaded Interlocking Screw, 3.3mm Core

ORTHOPEDIATRICS CORP.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00840194416276
NIH Device Record Key04923597-263e-4814-b7c7-87ee6108cb51
Commercial Distribution StatusIn Commercial Distribution
Brand NamePediatric Nailing Platform Femur
Version Model Number00-1506-6023
Catalog Number00-1506-6023
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(574)268-6379
Emailyli@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840194416276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840194416276]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-02-19
Device Publish Date2022-09-16

On-Brand Devices [Pediatric Nailing Platform Femur]

0084019441562010mm x 20mm End Cap, Retaining
0084019441561310mm x 15mm End Cap, Retaining
0084019441560610mm x 10mm End Cap, Retaining
0084019441559010mm x 5mm End Cap, Retaining
0084019441558310mm x 0mm End Cap, Flush, Retaining
0084019441557612mm x 500mm Adolescent Nail, Right
0084019441556912mm x 480mm Adolescent Nail, Right
0084019441555212mm x 460mm Adolescent Nail, Right
0084019441554512mm x 440mm Adolescent Nail, Right
0084019441553812mm x 500mm Adolescent Nail, Left
0084019441552112mm x 480mm Adolescent Nail, Left
0084019441551412mm x 460mm Adolescent Nail, Left
0084019441550712mm x 440mm Adolescent Nail, Left
0084019441549111mm x 500mm Adolescent Nail, Right
0084019441548411mm x 480mm Adolescent Nail, Right
0084019441547711mm x 460mm Adolescent Nail, Right
0084019441546011mm x 440mm Adolescent Nail, Right
0084019441545311mm x 500mm Adolescent Nail, Left
0084019441544611mm x 480mm Adolescent Nail, Left
0084019441543911mm x 460mm Adolescent Nail, Left
0084019441542211mm x 440mm Adolescent Nail, Left
0084019441541510mm x 500mm Adolescent Nail, Right
0084019441540810mm x 480mm Adolescent Nail, Right
0084019441539210mm x 460mm Adolescent Nail, Right
0084019441538510mm x 440mm Adolescent Nail, Right
0084019441537810mm x 500mm Adolescent Nail, Left
0084019441536110mm x 480mm Adolescent Nail, Left
0084019441535410mm x 460mm Adolescent Nail, Left
0084019441534710mm x 440mm Adolescent Nail, Left
008401944153309mm x 500mm Adolescent Nail, Right
008401944153239mm x 480mm Adolescent Nail, Right
008401944153169mm x 460mm Adolescent Nail, Right
008401944153099mm x 440mm Adolescent Nail, Right
008401944152939mm x 500mm Adolescent Nail, Left
008401944152869mm x 480mm Adolescent Nail, Left
008401944152799mm x 460mm Adolescent Nail, Left
008401944152629mm x 440mm Adolescent Nail, Left
008401944152559mm x 20mm End Cap, Retaining
008401944152489mm x 15mm End Cap, Retaining
008401944152319mm x 10mm End Cap, Retaining
008401944152249mm x 5mm End Cap, Retaining
008401944152179mm x 0mm End Cap, Flush, Retaining
008401944056692.0 X 450mm Smooth Wire
00840194405621PNP Extraction Chisel
00840194405614PNP Adolescent Hook Extractor
00840194405607PNP Child Hook Extractor
00840194405577PNP Screw Easy Out
00840194405560PNP Screw Easy Off
00840194405553PNP End Cap Easy Out
00840194405508Pedinail Conical Cannulated Extractor - Slap Hammer

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