Locking Proximal Femur Plate System 00-0907-4555

GUDID 00841132111598

4.5mm Self Tapping Cortical Screw with T20 Hexalobe, Size 55mm

ORTHOPEDIATRICS CORP.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00841132111598
NIH Device Record Keyb8ad43c0-f3a7-4bd8-83e6-9948e3571e50
Commercial Distribution StatusIn Commercial Distribution
Brand NameLocking Proximal Femur Plate System
Version Model Number00-0907-4555
Catalog Number00-0907-4555
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132111598 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [Locking Proximal Femur Plate System]

00841132124406130° X 3.5MM INFANT PLATE, 4-HOLE
00841132124390130° X 3.5MM INFANT PLATE, 3-HOLE
00841132124383130° X 3.5MM INFANT PLATE, 2-HOLE
00841132124376110° X 3.5MM INFANT PLATE, 4-HOLE, 6MM OFFSET
00841132124369110° X 3.5MM INFANT PLATE, 3-HOLE, 6MM OFFSET
00841132124352110° X 3.5MM INFANT PLATE, 2-HOLE, 6MM OFFSET
0084113212434590° X 3.5MM INFANT PLATE, 4-HOLE, 6MM OFFSET
0084113212433890° X 3.5MM INFANT PLATE, 3-HOLE, 6MM OFFSET
0084113212432190° X 3.5MM INFANT PLATE, 2-HOLE, 6MM OFFSET
00841132123928140º X 4.5MM PLATE, 6 HOLE
00841132123911140º X 4.5MM PLATE, 5 HOLE
00841132123904140º X 4.5MM PLATE, 3 HOLE
00841132123898140º X 3.5MM PLATE, 6 HOLE
00841132123881140º X 3.5MM PLATE, 5 HOLE
00841132123874140º X 3.5MM PLATE, 4 HOLE
00841132123867140º X 3.5MM PLATE, 3 HOLE
008411321122124.5mm CANNULATED LOCKING SCREW, 80mm
008411321122054.5mm CANNULATED LOCKING SCREW, 75mm
008411321121994.5mm CANNULATED LOCKING SCREW, 70mm
008411321121824.5mm CANNULATED LOCKING SCREW, 65mm
008411321121754.5mm CANNULATED LOCKING SCREW, 60mm
008411321121684.5mm CANNULATED LOCKING SCREW, 58mm
008411321121514.5mm CANNULATED LOCKING SCREW, 56mm
008411321121444.5mm CANNULATED LOCKING SCREW, 55mm
008411321121374.5mm CANNULATED LOCKING SCREW, 54mm
008411321121204.5mm CANNULATED LOCKING SCREW, 52mm
008411321121134.5mm CANNULATED LOCKING SCREW, 50mm
008411321121064.5mm CANNULATED LOCKING SCREW, 48mm
008411321120904.5mm CANNULATED LOCKING SCREW, 46mm
008411321120834.5mm CANNULATED LOCKING SCREW, 45mm
008411321120764.5mm CANNULATED LOCKING SCREW, 44mm
008411321120694.5mm CANNULATED LOCKING SCREW, 42mm
008411321120524.5mm CANNULATED LOCKING SCREW, 40mm
008411321120454.5mm CANNULATED LOCKING SCREW, 38mm
008411321120384.5mm CANNULATED LOCKING SCREW, 36mm
008411321120214.5mm CANNULATED LOCKING SCREW, 34mm
008411321120144.5mm CANNULATED LOCKING SCREW, 32mm
008411321120074.5mm CANNULATED LOCKING SCREW, 30mm
008411321119944.5mm CANNULATED LOCKING SCREW, 28mm
008411321119874.5MM LOCKING SCREW, T20 HEXALOBE, SELF TAPPING, 90MM
008411321119704.5MM LOCKING SCREW, T20 HEXALOBE, SELF TAPPING, 85MM
008411321119634.5mm LOCKING SCREW, 80mm
008411321119564.5mm LOCKING SCREW, 75mm
008411321119494.5mm LOCKING SCREW, 70mm
008411321119324.5mm LOCKING SCREW, 65mm
008411321119254.5mm LOCKING SCREW, 60mm
008411321119184.5mm LOCKING SCREW, 58mm
008411321119014.5mm LOCKING SCREW, 56mm
008411321118954.5mm LOCKING SCREW, 55mm
008411321118884.5mm LOCKING SCREW, 54mm
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