Ti6® Internal Fixation System FS1040

GUDID M269FS10401

Integra® Ti6® The screw removal tool is used in conjunction with the Integra Ti6 Screw system.

Ascension Orthopedics, Inc.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable
Primary Device IDM269FS10401
NIH Device Record Key28fcad13-7848-4405-b5bb-ef14037887a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTi6® Internal Fixation System
Version Model NumberFS1040
Catalog NumberFS1040
Company DUNS942377524
Company NameAscension Orthopedics, Inc.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS110381780244950 [Primary]
HIBCCM269FS10401 [Secondary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

[M269FS10401]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2017-09-05

On-Brand Devices [Ti6® Internal Fixation System]

M269FS40401Integra® Ti6® The removal driver shaft is used in conjunction with the Ti6 TH-series screws.
M269FS10401Integra® Ti6® The screw removal tool is used in conjunction with the Integra Ti6 Screw system.
M269FS10301Integra® Ti6® The forceps are used for screw pickup in the Integra Ti6 system.
M269FS10141Integra® Ti6® The Scarf Bone Reduction Forceps are used to hold objects in the Integra Ti6 sys
M269FS10121Integra® Ti6® The Bone Reduction Forceps are used to hold objects in the Integra Ti6 system. T
M269FS10101The Bone Reduction Forceps are used to hold objects in the Integra Ti6 system. These forceps hav
M269FS20601Integra® Ti6® The TS-series drill guide is used for precision and accuracy when drilling 3.0 a
M269FS20501Integra® Ti6® The TS-series drill guide is used for precision and accuracy when drilling 2.0 a
M269TT5000L1Integra® Ti6® The Ti6 Lid is the top part of the tray which locks onto the base and keeps cont
M269TT50001Integra® Ti6® TheTi6 Digital Fusion Instrument Sterilization Tray is designed to contain, secu
M269TT4000S1Integra® Ti6® The Ti6 sterilization tray, TH&TQ series instruments, is used to contain, secure
M269TT4000L1Integra® Ti6® The Ti6 Lid is the top part of the tray which locks onto the base and keeps cont
M269TT40001Integra® Ti6® TheTi6 TH & TQ Series Instrument Sterilization Tray is designed to contain, secu
M269TT3000L1Integra® Ti6® The Ti6 Lid is the top part of the tray which locks onto the base and keeps cont
M269TT30001Integra® Ti6® TheTi6 TC Series Instrument Sterilization Tray is designed to contain, secure, a
M269TT2000L1Integra® Ti6® The Ti6 Lid is the top part of the tray which locks onto the base and keeps cont
M269TT20001Integra® Ti6® TheTi6 TS Series Instrument Sterilization Tray is designed to contain, secure, a
M269TT1000L1Integra® Ti6® The Ti6 Lid is the top part of the tray which locks onto the base and keeps cont
M269TT10001Integra® Ti6® TheTi6 Sterilization Tray Base is the bottom portion wherein devices are placed.
M269TI6INSTP1Integra® Ti6® The Ti6 Base Instrument Set contains instruments used to aid in the implantation
M269FS20201Integra® Ti6® The driver shaft is used to create holes in conjunction with the Ti6 TS-series 3
M269FS20101Integra® Ti6® The driver shaft is used to create holes in conjunction with the Ti6 TS-series 2
M269FS20041Integra® Ti6® The drill bit is a cutting tool used to create 4.0 mm cylindrical holes.
M269FS20031Integra® Ti6® The drill bit is a cutting tool used to create 3.0 mm cylindrical holes.
M269FS20021Integra® Ti6® The drill bit is a cutting tool used to create 2.5 mm cylindrical holes.
M269FS20011Integra® Ti6® The drill bit is a cutting tool used to create 2.0 mm cylindrical holes.
M269DS30101Integra® Ti6® The driver shaft is used to create holes in conjunction with the Ti6 digital fus
M269DS10071Integra® Ti6® The ratchet handle is used in conjunction with the Digital Fusion screws.
M269KW1102P1Integra® Ti6® The threaded guide wire is used as a guide for placement or insertion of a devic
M269FS21851Integra® Ti6® The Ti6 cannulated CounterSink is used to add space or clearance for the head of
M269FS21751Integra® Ti6® The Ti6 cannulated CounterSink is used to add space or clearance for the head of
M269DW11111Integra® Ti6® The smooth guide wire is used as a guide for placement or insertion of a device.
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