Locking Proximal Femur 00-1050-6107

GUDID 00841132130063

4.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 7 Hole

ORTHOPEDIATRICS CORP.

Growth-correction orthopaedic fixation plate kit
Primary Device ID00841132130063
NIH Device Record Key97854a1d-9450-408a-b16b-406f87d92101
Commercial Distribution StatusIn Commercial Distribution
Brand NameLocking Proximal Femur
Version Model Number00-1050-6107
Catalog Number00-1050-6107
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exemptfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132130063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, 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 Date2016-10-31

On-Brand Devices [Locking Proximal Femur]

00841132132753LOCKING PROXIMAL FEMUR IMPLANT TRAY
00841132130391ORTHOPEDIATRICS LID, VERTICAL HANDLES
00841132130384TRAY 3: MODULAR TRAY FOR LOCKING PROXIMAL FEMORAL PLATE INSTRUMENTATION
00841132130377TRAY 8: LOCKING PROXIMAL FEMUR PLATES (4.5 MM)
00841132130360TRAY 7: LOCKING PROXIMAL FEMUR PLATES (3.5 MM)
00841132130353TRAY 1: BASE TRAY FOR 3.5 T15 AND 4.5 T20 SCREW INSTRUMENTATION
00841132130315LABEL FOR MODULAR SCREW CADDY, 3.5MM TRANS-PHYSEAL SCREWS
00841132130308MODULAR SCREW CADDY 3.5MM BLOCK, TRANS-PHYSEAL SCREWS
008411321302544.5mm 80° DFOS Plate, 5° Flare, No Offset, 8 Hole
008411321302474.5mm 80° DFOS Plate, 5° Flare, No Offset, 7 Hole
008411321302304.5mm 80° DFOS Plate, 5° Flare, No Offset, 6 Hole
008411321302234.5mm 80° DFOS Plate, 5° Flare, No Offset, 5 Hole
008411321302164.5mm 80° DFOS Plate, 5° Flare, No Offset, 4 Hole
008411321302094.5mm 80° DFOS Plate, 5° Flare, No Offset, 3 Hole
008411321301933.5mm 80° DFOS Plate, 5° Flare, No Offset, 8 Hole
008411321301863.5mm 80° DFOS Plate, 5° Flare, No Offset, 7 Hole
008411321301793.5mm 80° DFOS Plate, 5° Flare, No Offset, 6 Hole
008411321301623.5mm 80° DFOS Plate, 5° Flare, No Offset, 5 Hole
008411321301553.5mm 80° DFOS Plate, 5° Flare, No Offset, 4 Hole
008411321301483.5mm 80° DFOS Plate, 5° Flare, No Offset, 3 Hole
008411321301314.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 8 Hole
008411321301244.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 7 Hole
008411321301174.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 6 Hole
008411321301004.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 5 Hole
008411321300944.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 4 Hole
008411321300874.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 3 Hole
008411321300704.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 8 Hole
008411321300634.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 7 Hole
008411321300564.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 6 Hole
008411321300494.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 5 Hole
008411321300324.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 4 Hole
008411321300254.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 3 Hole
008411321300184.5mm 90° DFOS Plate, 5° Flare, No Offset, 8 Hole
008411321300014.5mm 90° DFOS Plate, 5° Flare, No Offset, 7 Hole
008411321299994.5mm 90° DFOS Plate, 5° Flare, No Offset, 6 Hole
008411321299824.5mm 90° DFOS Plate, 5° Flare, No Offset, 5 Hole
008411321299754.5mm 90° DFOS Plate, 5° Flare, No Offset, 4 Hole
008411321299684.5mm 90° DFOS Plate, 5° Flare, No Offset, 3 Hole
008411321299513.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 8 Hole
008411321299443.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 7 Hole
008411321299373.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 6 Hole
008411321299203.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 5 Hole
008411321299133.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 4 Hole
008411321299063.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 3 Hole
008411321298903.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 8 Hole
008411321298833.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 7 Hole
008411321298763.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 6 Hole
008411321298693.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 5 Hole
008411321298523.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 4 Hole
008411321298453.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 3 Hole

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