Locking Proximal Femur System 01-0907-0100

GUDID 00841132135693

INFANT LPF PROXIMAL FIXATION 1.6MM WIRE GUIDE

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00841132135693
NIH Device Record Key9efe4e62-0185-42fe-bed2-99ecf37f56a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameLocking Proximal Femur System
Version Model Number01-0907-0100
Catalog Number01-0907-0100
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132135693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FZXGuide, surgical, instrument
OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

[00841132135693]

Moist Heat or Steam Sterilization

[00841132135693]

Moist Heat or Steam Sterilization

[00841132135693]

Moist Heat or Steam Sterilization

[00841132135693]

Moist Heat or Steam Sterilization

[00841132135693]

Moist Heat or Steam Sterilization

[00841132135693]

Moist Heat or Steam Sterilization

[00841132135693]

Moist Heat or Steam Sterilization

[00841132135693]

Moist Heat or Steam Sterilization

[00841132135693]

Moist Heat or Steam Sterilization

[00841132135693]

Moist Heat or Steam Sterilization

[00841132135693]

Moist Heat or Steam Sterilization

[00841132135693]

Moist Heat or Steam Sterilization

[00841132135693]

Moist Heat or Steam Sterilization

[00841132135693]

Moist Heat or Steam Sterilization

[00841132135693]

Moist Heat or Steam Sterilization

[00841132135693]

Moist Heat or Steam Sterilization

[00841132135693]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-02-15

On-Brand Devices [Locking Proximal Femur System]

00841132136386TRAY 3 - MODULAR TRAY FOR LOCKING PROXIMAL FEMUR
00841132136379TRAY 8 - LOCKING PROXIMAL FEMUR PLATES (4.5MM)
00841132136362TRAY 7 - LOCKING PROXIMAL FEMUR PLATES (3.5MM)
00841132136355TRAY 1 - BASE TRAY FOR 3.5 T15 AND 4.5 T20 SCREW
00841132135709INFANT LPF PROXIMAL FIXATION 2.5MM WIRE GUIDE
00841132135693INFANT LPF PROXIMAL FIXATION 1.6MM WIRE GUIDE
00841132135686INFANT LPF CASE LID
00841132135679INFANT LPF CASE
00841132135594130° X 3.5MM INFANT PLATE, 4-HOLE
00841132135587130° X 3.5MM INFANT PLATE, 3-HOLE
00841132135570130° X 3.5MM INFANT PLATE, 2-HOLE
00841132135563110° X 3.5MM INFANT PLATE, 3-HOLE, 6MM OFFSET
00841132135556110° X 3.5MM INFANT PLATE, 2-HOLE, 6MM OFFSET
0084113213554990° X 3.5MM INFANT PLATE, 4-HOLE, 6MM OFFSET
0084113213553290° X 3.5MM INFANT PLATE, 3-HOLE, 6MM OFFSET
0084113213552590° X 3.5MM INFANT PLATE, 2-HOLE, 6MM OFFSET
00841132133170LOCKING PROXIMAL FEMUR PLATE SYSTEM 4.5 IMPLANT SET
00841132133163LOCKING PROXIMAL FEMUR PLATE SYSTEM 3.5 IMPLANT SET
00841132133156LOCKING PROXIMAL FEMUR PLATE SYSTEM SCREW CADDY
00841132133149LOCKING PROXIMAL FEMUR PLATE SYSTEM IMPLANT SET
00841132133132PROXIMAL FEMUR LOCKING PLATE SYSTEM INSTRUMENT TRAY
00841132133125PROXIMAL FEMUR LOCKING PLATE SYSTEM INSTRUMENT BASE
00841132133118PROXIMAL FEMUR LOCKING PLATE SYSTEM INSTRUMENT TRAY
00841132133101PROXIMAL FEMUR LOCKING PLATE SYSTEM INSTRUMENT BASE
00841132133095LOCKING PROXIMAL FEMUR PLATE SYSTEM INSTRUMENT SET
00841132133088PROXIMAL FEMUR LOCKING PLATE SYSTEM INSTRUMENT SET
00841132133071PROXIMAL FEMUR LOCKING PLATE SYSTEM 4.5 SCREW CADDY LID
00841132133064PROXIMAL FEMUR LOCKING PLATE SYSTEM 4.5 SCREW CADDY
00841132133057PROXIMAL FEMUR LOCKING PLATE SYSTEM 4.5 PLATE TRAY
00841132133040PROXIMAL FEMUR LOCKING PLATE SYSTEM 4.5 OFFSET PLATE TRAY
00841132133033PROXIMAL FEMUR LOCKING PLATE SYSTEM 4.5 IMPLANT BASE
00841132133026PROXIMAL FEMUR LOCKING PLATE SYSTEM 3.5 SCREW CADDY LID
00841132133019PROXIMAL FEMUR LOCKING PLATE SYSTEM 3.5 SCREW CADDY
00841132133002PROXIMAL FEMUR LOCKING PLATE SYSTEM 3.5 PLATE TRAY
00841132132999PROXIMAL FEMUR LOCKING PLATE SYSTEM 3.5 OFFSET PLATE TRAY
00841132132982PROXIMAL FEMUR LOCKING PLATE SYSTEM 3.5 IMPLANT BASE
00841132132975PROXIMAL FEMUR LOCKING PLATE SYSTEM 4.5 IMPLANT
00841132132968PROXIMAL FEMUR LOCKING PLATE SYSTEM 3.5 IMPLANT
00841132132951PROXIMAL FEMUR LOCKING PLATE SYSTEM IMPLANT SCREW CADDY BASE
00841132132944PROXIMAL FEMUR LOCKING PLATE SYSTEM LID
00841132132937PROXIMAL FEMUR LOCKING PLATE SYSTEM SCREW CADDY LID
00841132132920PROXIMAL FEMUR LOCKING PLATE SYSTEM SCREW CADDY
00841132132913PROXIMAL FEMUR LOCKING PLATE SYSTEM IMPLANT TRAY
00841132132906PROXIMAL FEMUR LOCKING PLATE SYSTEM IMPLANT BASE
00841132132890LOCKING PROXIMAL FEMUR PLATE SYSTEM - 8 AND 10 HOLE
00841132132883LOCKING PROXIMAL FEMUR FX SYSTEM
008411321228392.5MM DRILL BIT
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