RIVAL VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM 002-H-00010

GUDID 18053340341066

EVANS PLATE, 10MM SPACER This record replaces UDI: 18056099647748

ORTHOFIX SRL

Orthopaedic fixation plate, non-bioabsorbable, sterile
Primary Device ID18053340341066
NIH Device Record Keye590940d-823f-4b12-9c0c-9e6fb4608f19
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIVAL VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM
Version Model Number2
Catalog Number002-H-00010
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 Numberfalse
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+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it

Device Dimensions

Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118053340341066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

[18053340341066]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-06
Device Publish Date2019-10-29

On-Brand Devices [RIVAL VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM]

18053340341240RIVAL TI H-PLATE 30MM (present record replaces device with Primary DI: 18053800893760
18053340341233RIVAL TI H-PLATE 25MM (present record replaces device with Primary DI: 18053800893753
18053340341226RIVAL TI H-PLATE 20MM (present record replaces device with Primary DI: 18053800893739
18053340341219RIVAL TI H-PLATE 15MM (present record replaces device with Primary DI: 18053800893715
18053340341202RIVAL TI H-PLATE 12MM (present record replaces device with Primary DI: 18053800893708
18053340341196RIVAL TI BOX PLATE 30MM (present record replaces device with Primary DI: 18053800893692
18053340341189RIVAL TI BOX PLATE 22MM (present record replaces device with Primary DI: 18053800893678
18053340341172RIVAL TI BOX PLATE 18MM (present record replaces device with Primary DI: 18053800893654
18053340341165RIVAL TI L-PLATE RIGHT (present record replaces device with Primary DI: 18053800893647
18053340341158RIVAL TI L-PLATE LEFT (present record replaces device with Primary DI: 18053800893630
18053340341141RIVAL TI STRAIGHT PLATE 6 HOLE (present record replaces device with Primary DI: 18053800893623
18053340341134RIVAL TI STRAIGHT PLATE 4 HOLE (present record replaces device with Primary DI: 18053800893616
18053340341127RIVAL TI STRAIGHT PLATE 3 HOLE (present record replaces device with Primary DI: 18053800893609
18053340341110Y-PLATE, LARGE This record replaces UDI: 18056099647793
18053340341103RIVAL TI Y-PLATE SMALL (present record replaces device with Primary DI: 18053800893586
18053340341097RIVAL TI T-PLATE LARGE (present record replaces device with Primary DI: 18053800893579
18053340341080T-PLATE, SMALL This record replaces UDI: 18056099647762
18053340341073RIVAL TI EVANS PLATE 12MM SPACER (present record replaces device with Primary DI: 1805380089355
18053340341066EVANS PLATE, 10MM SPACER This record replaces UDI: 18056099647748
18053340341059RIVAL TI EVANS PLATE 10MM SPACER (present record replaces device with Primary DI: 1805380089354
18053340341042RIVAL TI EVANS PLATE 6MM SPACER (present record replaces device with Primary DI: 18053800893524
18053340341035RIVAL TI CC PLATE LARGE (present record replaces device with Primary DI: 18053800893517
18053340341028RIVAL TI CC PLATE MEDIUM (present record replaces device with Primary DI: 18053800893500
18053340341011RIVAL TI CC PLATE SMALL (present record replaces device with Primary DI: 18053800893494
18053340341004RIVAL TI TN PLATE LARGE (present record replaces device with Primary DI: 18053800893487
18053340340991RIVAL TI TN PLATE MEDIUM (present record replaces device with Primary DI: 18053800893470
18053340340984RIVAL TI TN PLATE SMALL (present record replaces device with Primary DI: 18053800893463
18053340340977RIVAL TI LAPIDUS PLATE LARGE 2MM STEP RIGHT (present record replaces device with Primary DI: 18
18053340340960RIVAL TI LAPIDUS PLATE LARGE 2MM STEP LEFT (present record replaces device with Primary DI: 180
18053340340953RIVAL TI LAPIDUS PLATE LARGE 0MM STEP RIGHT (present record replaces device with Primary DI: 18
18053340340946RIVAL TI LAPIDUS PLATE LARGE 0MM STEP LEFT (present record replaces device with Primary DI: 180
18053340340939RIVAL TI LAPIDUS PLATE SMALL 2MM STEP RIGHT (present record replaces device with Primary DI: 18
18053340340922RIVAL TI LAPIDUS PLATE SMALL 2MM STEP LEFT (present record replaces device with Primary DI: 180
18053340340915RIVAL TI LAPIDUS PLATE SMALL 0MM STEP RIGHT (present record replaces device with Primary DI: 18
18053340340908RIVAL TI LAPIDUS PLATE SMALL 0MM STEP LEFT (present record replaces device with Primary DI: 180
18053340340892RIVAL TI MTP PLATE LARGE (present record replaces device with Primary DI: 18053800893371
18053340340885RIVAL TI MTP PLATE MEDIUM (present record replaces device with Primary DI: 18053800893364
18053340340878RIVAL TI MTP PLATE SMALL (present record replaces device with Primary DI: 18053800893357
18053340340861RIVAL TI H-PLATE 30MM STERILE
18053340340854RIVAL TI H-PLATE 25MM STERILE
18053340340847RIVAL TI H-PLATE 20MM STERILE
18053340340830RIVAL TI H-PLATE 15MM STERILE
18053340340823RIVAL TI H-PLATE 12MM STERILE
18053340340816RIVAL TI BOX PLATE 30MM STERILE
18053340340809RIVAL TI BOX PLATE 22MM STERILE
18053340340793RIVAL TI BOX PLATE 18MM STERILE
18053340340786RIVAL TI L-PLATE RIGHT STERILE
18053340340779RIVAL TI L-PLATE LEFT STERILE
18053340340762RIVAL TI STRAIGHT PLATE 6 HOLE STERILE
18053340340755RIVAL TI STRAIGHT PLATE 4 HOLE STERILE
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