Locking Proximal Femur Plate System (LPF) 01-0907-0010

GUDID 00841132122310

3.5 MM CANNULATED DRILL BIT

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00841132122310
NIH Device Record Key5320f29c-42e5-4cd0-ad8c-6bb5d5404ad9
Commercial Distribution StatusIn Commercial Distribution
Brand NameLocking Proximal Femur Plate System (LPF)
Version Model Number01-0907-0010
Catalog Number01-0907-0010
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132122310 [Primary]

FDA Product Code

GFGBIT, SURGICAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841132122310]

Moist Heat or Steam Sterilization


[00841132122310]

Moist Heat or Steam Sterilization


[00841132122310]

Moist Heat or Steam Sterilization


[00841132122310]

Moist Heat or Steam Sterilization


[00841132122310]

Moist Heat or Steam Sterilization


[00841132122310]

Moist Heat or Steam Sterilization


[00841132122310]

Moist Heat or Steam Sterilization


[00841132122310]

Moist Heat or Steam Sterilization


[00841132122310]

Moist Heat or Steam Sterilization


[00841132122310]

Moist Heat or Steam Sterilization


[00841132122310]

Moist Heat or Steam Sterilization


[00841132122310]

Moist Heat or Steam Sterilization


[00841132122310]

Moist Heat or Steam Sterilization


[00841132122310]

Moist Heat or Steam Sterilization


[00841132122310]

Moist Heat or Steam Sterilization


[00841132122310]

Moist Heat or Steam Sterilization


[00841132122310]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-28
Device Publish Date2023-06-20

On-Brand Devices [Locking Proximal Femur Plate System (LPF)]

00841132123676140° X 4.5MM PLATE, 4 HOLE
00841132122440Ø 1.6MM X Ø600MM GUIDE WIRE, BLUNT
008411321224333.2MM X 200MM GUIDE WIRE, SMOOTH
008411321224265.0MM X 200MM GUIDE WIRE, SMOOTH
008411321224192.0MM X 230MM GUIDE WIRE, SMOOTH
008411321224021.6MM X 230MM GUIDE WIRE, SMOOTH
008411321223962.0MM X 150MM GUIDE WIRE, SMOOTH
008411321223892.5MM X 200MM GUIDE WIRE, COCR
008411321223722.0 MM X 150 MM GUIDE WIRE (COCR)
008411321223652.0MM X 230MM GUIDE WIRE, COCR
008411321223581.6MM X 230MM GUIDE WIRE, COCR
008411321223412.0 MM X 150 MM GUIDE WIRE
00841132122334T20 CANNULATED DRIVER
00841132122327T15 CANNULATED DRIVER
008411321223103.5 MM CANNULATED DRILL BIT
008411321223032.9 MM CANNULATED DRILL BIT
008411321222972.0MM X 230MM GUIDE WIRE
008411321222801.6MM X 230MM GUIDE WIRE
00841132122273T15 RETAINING DRIVER, SHORT
00841132122266T15 HEXALOBE DRIVER, SHORT
008411321000423.2MM X 200MM GUIDE WIRE, COCR
0084113210003590° X 3.5 MM VARUS PLATE 6 MM OFFSET, 3 HOLE
00840194462983130° X 4.5MM VALGUS PLATES, 6MM OFFSET, 5 HOLE
00840194462976130° X 4.5MM VALGUS PLATES, 6MM OFFSET, 4 HOLE
00840194462969130° X 4.5MM VALGUS PLATES, 6MM OFFSET, 3 HOLE
00840194462952130° X 4.5MM VALGUS PLATES,14MM OFFSET, 5 HOLE
00840194462945130° X 4.5MM VALGUS PLATES,14MM OFFSET, 4 HOLE
00840194462938130° X 4.5MM VALGUS PLATES,14MM OFFSET, 3 HOLE

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