Contours Proximal Humeral Plate (Php) & Lsp Titani TP1001

GUDID 18032568869460

LSP LEFT HUMERUS TITANIUM PLATE

ORTHOFIX SRL

Orthopaedic fixation plate, non-bioabsorbable, sterile
Primary Device ID18032568869460
NIH Device Record Keyd0796bf7-d7f9-40ef-aaf1-8224b69bac69
Commercial Distribution StatusIn Commercial Distribution
Brand NameContours Proximal Humeral Plate (Php) & Lsp Titani
Version Model Number1
Catalog NumberTP1001
Company DUNS438793622
Company NameORTHOFIX SRL
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it

Device Identifiers

Device Issuing AgencyDevice ID
GS118032568869460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


[18032568869460]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [Contours Proximal Humeral Plate (Php) & Lsp Titani]

18054242510628PHP TRAY EMPTY
18054242510604QUICK CONNECT SCREWDRIVER FOR HEXAGONAL HEAD
180542425105983.5 MM QUICK CONNECT SCREWDRIVER
18054242510581LOCKING T-WRENCH
18054242510567HANDLE (SOFT TOUCH) QUICK CONNECT
18054242510543DRILL BIT (D. 3.2MM) QUICK CONNECT
18054242510536CANNULATED DRILL BIT (D. 4.8MM) QUICK CONNECT
18032937169818LSP STERIBOX, EMPTY
180329371698013,5 MM QUICK CONNECT SCREWDRIVER
18032937169795TITANIUM HEXAGONAL THREADED WIRES D.2,2 MM 120/55 MM (PACK OF 2)
18032937169788TITANIUM HEXAGONAL THREADED WIRES D.2,2 MM 120/50 MM (PACK OF 2)
18032937169771TITANIUM HEXAGONAL THREADED WIRES D.2,2 MM 120/45 MM (PACK OF 2)
18032937169764TITANIUM HEXAGONAL THREADED WIRES D.2,2 MM 120/40 MM (PACK OF 2)
18032937169757TITANIUM HEXAGONAL THREADED WIRES D.2,2 MM 120/35 MM (PACK OF 2)
18032937169740TITANIUM HEXAGONAL THREADED WIRES D.2,2 MM 120/30 MM (PACK OF 2)
18032937169733TITANIUM HEXAGONAL THREADED WIRES D.2,2 MM 120/25 MM (PACK OF 2)
18032937169726TITANIUM HEXAGONAL THREADED WIRES D.2,2 MM 120/20 MM (PACK OF 2)
18032937169450TITANIUM CANCELLOUS SCREW HUMERUS PLATE L.34 MM
18032937169443TITANIUM CANCELLOUS SCREW HUMERUS PLATE L.32 MM
18032937169436TITANIUM CANCELLOUS SCREW HUMERUS PLATE L.30 MM
18032937169429TITANIUM CANCELLOUS SCREW HUMERUS PLATE L.28 MM
18032937169412TITANIUM CANCELLOUS SCREW HUMERUS PLATE L.26 MM
18032937169405TITANIUM THREAD WIRE L. 120/55 MM THREAD D 2.2 MM (PACK OF 2)
18032937169399TITANIUM THREAD WIRE L. 120/50 MM THREAD D 2.2 MM (PACK OF 2)
18032937169337TITANIUM THREAD WIRE L. 120/20 MM THREAD D 2.2 MM (PACK OF 2)
18032937169306SCREW DRIVER
18032937169290DRILL D.3,2 X 200 MM
18032937169276PLATE HOLDER
18032568869514K-WIRE D.2X200 MM
18032568869507STINMANN-PIN L. 150 MM
18032568869477LSP RIGHT HUMERUS TITANIUM PLATE
18032568869460LSP LEFT HUMERUS TITANIUM PLATE
18032568869453TITANIUM CENTRAL SCREW HUMERUS PLATE THREAD L.40 MM
18032568869446TITANIUM CENTRAL SCREW HUMERUS PLATE THREAD L.45 MM
18032568869439TITANIUM CENTRAL SCREW HUMERUS PLATE THREAD L.50 MM
18032568869422TITANIUM CENTRAL SCREW HUMERUS PLATE THREAD L.60 MM
18032568869415TITANIUM CENTRAL SCREW HUMERUS PLATE THREAD L.55 MM
18032568869408TITANIUM DISTAL SCREW HUMERUS PLATE L.22 MM
18032568869392TITANIUM DISTAL SCREW HUMERUS PLATE L.24 MM
18032568869385TITANIUM DISTAL SCREW HUMERUS PLATE L.26 MM
18032568869378TITANIUM DISTAL SCREW HUMERUS PLATE L.28 MM
18032568869361TITANIUM DISTAL SCREW HUMERUS PLATE L.30 MM
18032568869354TITANIUM DISTAL SCREW HUMERUS PLATE L.32 MM
18032568869347TITANIUM DISTAL SCREW HUMERUS PLATE L.34 MM
18032568869330TITANIUM DISTAL SCREW HUMERUS PLATE L.36 MM

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.