Fitbone Trochanteric 99-O4OL18B10

GUDID 18059015376111

OSCAR PRO TITANIUM FLAT BLADE SMOOTH L180MM W10MM STERILE

ORTHOFIX SRL

Hard/soft-tissue ultrasonic surgical system
Primary Device ID18059015376111
NIH Device Record Keycb70d9c4-715f-46de-8c1c-26fc3405c4b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameFitbone Trochanteric
Version Model Number99-O4OL18B10
Catalog Number99-O4OL18B10
Company DUNS438793622
Company NameORTHOFIX SRL
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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

Device Dimensions

Length180 Millimeter
Width10 Millimeter
Length180 Millimeter
Width10 Millimeter
Length180 Millimeter
Width10 Millimeter
Length180 Millimeter
Width10 Millimeter
Length180 Millimeter
Width10 Millimeter
Length180 Millimeter
Width10 Millimeter
Length180 Millimeter
Width10 Millimeter
Length180 Millimeter
Width10 Millimeter
Length180 Millimeter
Width10 Millimeter
Length180 Millimeter
Width10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118059015376111 [Primary]

FDA Product Code

JDXInstrument, surgical, sonic and accessory/attachment

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-22
Device Publish Date2025-07-14

Devices Manufactured by ORTHOFIX SRL

18059015376111 - Fitbone Trochanteric2025-07-22OSCAR PRO TITANIUM FLAT BLADE SMOOTH L180MM W10MM STERILE
18059015376111 - Fitbone Trochanteric2025-07-22 OSCAR PRO TITANIUM FLAT BLADE SMOOTH L180MM W10MM STERILE
18059015376739 - TRUELOK SYSTEM2025-07-22 DRILL GUIDE D3.2MM L60MM
18059015376746 - TRUELOK SYSTEM2025-07-22 DRILL GUIDE D3.2MM L40MM
18059015376753 - TRUELOK SYSTEM2025-07-22 DRILL GUIDE D3.2MM L80MM
18052469476055 - MINI-FIXATION SYSTEMS2025-06-17 CALCFIX PLUS CALCANEAL FIXATOR
18052469476086 - MINI-FIXATION SYSTEMS2025-06-17 CALCFIX PLUS CALCANEAL FIXATOR STERILE
18052469476406 - MINI-FIXATION SYSTEMS2025-06-17 CALCFIX PLUS CALCANEAL FIXATOR SET STERILE
18053504362852 - VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM2025-06-17 RIVAL TI NON-LOCKING SCREW L8MM THREAD D2.0MM STERILE
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.