Ankle Compression Nailing System 99-T77230

GUDID 18054242512981

TITANIUM ANKLE HINDFOOT NAIL 12/300

ORTHOFIX SRL

Arthrodesis nail, sterile Arthrodesis nail, sterile Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length
Primary Device ID18054242512981
NIH Device Record Keyae8a49a0-d02e-4b12-a494-d1e09510de4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnkle Compression Nailing System
Version Model Number1
Catalog Number99-T77230
Company DUNS438793622
Company NameORTHOFIX SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
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

Device Dimensions

Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter
Length300 Millimeter
Outer Diameter12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118054242512981 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-08

On-Brand Devices [Ankle Compression Nailing System]

18054242512981TITANIUM ANKLE HINDFOOT NAIL 12/300
18054242512974TITANIUM ANKLE HINDFOOT NAIL 12/250
18054242512967TITANIUM ANKLE HANDFOOT NAIL 12/200
18054242512950TITANIUM ANKLE HINDFOOT NAIL 12/150
18054242512943TITANIUM ANKLE HINDFOOT NAIL 11/300
18054242512936TITANIUM ANKLE HINDFOOT NAIL 11/250
18054242512929SHORT RETROGRADE NAIL STERILE DIAMETER 11 MM LENGTH 200 MM
18054242512912TITANIUM ANKLE HINDFOOT NAIL 11/150
18054242512905TITANIUM ANKLE HINDFOOT NAIL 10/300
18054242512899TITANIUM ANKLE HINDFOOT NAIL 10/250
18054242512882TITANIUM ANKLE HINDFOOT NAIL 10/200
18054242512875TITANIUM ANKLE HINDFOOT NAIL 10/150
18054242512868ANKLE HINDFOOT NAILING SYSTEM - DRILLS AND REAMERS CASE EMPTY
18054242512851ANKLE HINDFOOT NAILING SYSTEM - INSERTION INSTRUMENTS CASE EMPTY
18054242512844ANKLE HINDFOOT NAILING SYSTEM - EXTRACTION INSTRUMENTS CASE EMPTY
18054242512837CROSS-THREADING ADAPTOR
18054242512820SLAP HAMMER ADAPTOR
18054242512813NEEDLE NOSE VISE GRIPS
18054242512806SCREW HEAD GOUGE
18054242512790SCREW EXTRACTOR, SIZE 5
18054242512783SCREW EXTRACTOR, SIZE 4
18054242512271TITANIUM LOW PROFILE SCREW, D 5MM L 37.5MM
18054242512264TITANIUM LOW PROFILE SCREW, D 5MM L 32.5MM
18054242511571TITANIUM LOW PROFILE SCREW, D 5MM L 27.5MM
18054242511564TITANIUM LOW PROFILE SCREW, D 5MM L 22.5MM
18054242511458TITANIUM CALCANEUS THREADED HEAD SCREW D 5MM L 60MM
18054242511441TITANIUM CALCANEUS THREADED HEAD SCREW D 5MM L 65MM
18054242510154PLASTIC INSERT FOR SLOTTED MALLET
180335098591751.8 X 350MM GUIDE-WIRE
18033509859168ANKLE COMPRESSION DRILLS AND REAMERS TRAY EMPTY
18033509859151ANKLE COMPRESSION INSERTION INSTRUMENTS TRAY EMPTY
18033509859144LOCKING CAM
18033509859137COUNTERSINK
18033509859120LOCKING END CAP 10 MM
18033509859113LOCKING END CAP 5 MM
18033509859106LOCKING END CAP 0 MM
18033509859090SHORT DEPTH GAUGE
180335098590834.3MM FREEHAND DRILL
1803350985907624MM WRENCH
18033509859069LONG DEPTH GAUGE
18033509859052LOCKING DRIVER
18033509859045COMPRESSION DRIVER
180335098590383.5MM HEX SCREW DRIVER
18033509859021RATCHETING STRAIGHT HANDLE
18033509859014RATCHETING T-HANDLE
180335098590076.1MM DRILL FOR THREADED HEAD SCREW
180335098589944.3MM CALIBRATED DRILL
18033509858987TROCAR
180335098589704.3MM DRILL GUIDE
18033509858963SCREW GUIDE
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