FITBONE TAA SYSTEM 60000398

GUDID 18053340342308

FITBONE DRILL BIT D4.5MM

ORTHOFIX SRL

Fluted surgical drill bit, reusable
Primary Device ID18053340342308
NIH Device Record Key6197b520-194d-464c-9b76-853b450e6da8
Commercial Distribution StatusIn Commercial Distribution
Brand NameFITBONE TAA SYSTEM
Version Model Number1
Catalog Number60000398
Company DUNS438793622
Company NameORTHOFIX SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Device Dimensions

Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118053340342308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18053340342308]

Moist Heat or Steam Sterilization

[18053340342308]

Moist Heat or Steam Sterilization

[18053340342308]

Moist Heat or Steam Sterilization

[18053340342308]

Moist Heat or Steam Sterilization

[18053340342308]

Moist Heat or Steam Sterilization

[18053340342308]

Moist Heat or Steam Sterilization

[18053340342308]

Moist Heat or Steam Sterilization

[18053340342308]

Moist Heat or Steam Sterilization

[18053340342308]

Moist Heat or Steam Sterilization

[18053340342308]

Moist Heat or Steam Sterilization

[18053340342308]

Moist Heat or Steam Sterilization

[18053340342308]

Moist Heat or Steam Sterilization

[18053340342308]

Moist Heat or Steam Sterilization

[18053340342308]

Moist Heat or Steam Sterilization

[18053340342308]

Moist Heat or Steam Sterilization

[18053340342308]

Moist Heat or Steam Sterilization

[18053340342308]

Moist Heat or Steam Sterilization

[18053340342308]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-20
Device Publish Date2023-04-12

On-Brand Devices [FITBONE TAA SYSTEM]

18053340345378FITBONE DUMMY TAA0940-T-200
18053340345361FITBONE DUMMY TAA0940-F-200
18053340344951FITBONE STEP REAMER TAA0940
18053340344906FITBONE CONE C13 RETROPATELLAR
18053340344869FITBONE DUMMY TAA0960-T-220
18053340344852FITBONE DUMMY TAA0960-F-220
18053340344845FITBONE STEP REAMER TAA0960
18053340344838FITBONE DRILL BIT L300MM D4MM
18053340344807FITBONE LOCKING SCREW SHORT THREAD L35MM D4MM
18053340344791FITBONE LOCKING SCREW SHORT THREAD L30MM D4MM
18053340344784FITBONE LOCKING SCREW SHORT THREAD L25MM D4MM
18053340344777FITBONE LOCKING SCREW SHORT THREAD L20MM D4MM
18053340344418FITBONE DUMMY TAA1380-F-245
18053340344227FITBONE STEP REAMER TAA1140
18053340344159FITBONE DUMMY TAA1180-T-245
18053340344050FITBONE GRID PLATE
18053340344005FITBONE TARGETING DEVICE 45°/90°
18053340343985FITBONE STEP REAMER TAA1160 OVERSIZE
18053340343978FITBONE STEP REAMER TAA1180 OVERSIZE
18053340343961FITBONE STEP REAMER TAA1160
18053340343879FITBONE WIRE CATCHER 90 DEG
18053340343831FITBONE DUMMY TAA1140-F-205
18053340343817FITBONE DUMMY TAA1140-T-205
18053340343794FITBONE DRILL GUIDE BLOCK SCREWS TAA11
18053340343787FITBONE OUTRIGGER TAA
18053340343770FITBONE STEP REAMER TAA1180
18053340343763FITBONE DRILL GUIDE TAA
18053340343756FITBONE DUMMY TAA1160-F-225
18053340343732FITBONE TUBE-SINKER TS14
18053340343725FITBONE TUBE-SINKER TS15
18053340343718FITBONE CONE C14
18053340343701FITBONE CONE C15++
18053340343695FITBONE CONE C15+
18053340343688FITBONE CONE C15
18053340343671FITBONE TUBE T13/12-XL
18053340343664FITBONE TUBE T14/13-XL
18053340343657FITBONE TUBE T15/14-XL
18053340343640FITBONE TUBE T16/15-XL
18053340343633FITBONE TUBE T13/12-L
18053340343626FITBONE TUBE T14/13-L
18053340343619FITBONE TUBE T15/14-L
18053340343602FITBONE TUBE T16/15-L
18053340343596FITBONE TUBE T15/14-M
18053340343589FITBONE TUBE T16/15-M
18053340343572FITBONE TUBE T12/08-S
18053340343565FITBONE TUBE T12/09-S
18053340343558FITBONE TUBE T12/10-S
18053340343541FITBONE TUBE T12/11-S
18053340343534FITBONE TUBE T13/12-S
18053340343527FITBONE TUBE T14/13-S
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.