Tornier Perform Humeral System IFX514

GUDID 00846832086344

Fracture Rasp Extension

TORNIER, INC.

Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID00846832086344
NIH Device Record Key10b50a35-66c5-4182-b0c2-9aef7e9c9819
Commercial Distribution StatusIn Commercial Distribution
Brand NameTornier Perform Humeral System
Version Model NumberIFX514
Catalog NumberIFX514
Company DUNS968990812
Company NameTORNIER, INC.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
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+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com

Device Dimensions

Length210 Millimeter
Device Size Text, specify0
Length210 Millimeter
Device Size Text, specify0
Length210 Millimeter
Device Size Text, specify0
Length210 Millimeter
Device Size Text, specify0
Length210 Millimeter
Device Size Text, specify0
Length210 Millimeter
Device Size Text, specify0
Length210 Millimeter
Device Size Text, specify0
Length210 Millimeter
Device Size Text, specify0
Length210 Millimeter
Device Size Text, specify0
Length210 Millimeter
Device Size Text, specify0
Length210 Millimeter
Device Size Text, specify0
Length210 Millimeter
Device Size Text, specify0
Length210 Millimeter
Device Size Text, specify0
Length210 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100846832086344 [Primary]

FDA Product Code

KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00846832086344]

Moist Heat or Steam Sterilization


[00846832086344]

Moist Heat or Steam Sterilization


[00846832086344]

Moist Heat or Steam Sterilization


[00846832086344]

Moist Heat or Steam Sterilization


[00846832086344]

Moist Heat or Steam Sterilization


[00846832086344]

Moist Heat or Steam Sterilization


[00846832086344]

Moist Heat or Steam Sterilization


[00846832086344]

Moist Heat or Steam Sterilization


[00846832086344]

Moist Heat or Steam Sterilization


[00846832086344]

Moist Heat or Steam Sterilization


[00846832086344]

Moist Heat or Steam Sterilization


[00846832086344]

Moist Heat or Steam Sterilization


[00846832086344]

Moist Heat or Steam Sterilization


[00846832086344]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-05-03
Device Publish Date2022-12-21

On-Brand Devices [Tornier Perform Humeral System]

00846832093496Fracture Stem Screw
00846832093489Fracture Stem Screw
00846832093472Fracture Stem Screw
00846832093465Fracture Stem Screw
00846832093458Fracture Stem Screw
00846832093441Fracture Stem Screw
00846832093434Fracture Stem Screw
00846832093427Fracture Stem Screw
00846832093410Fracture Stem Screw
00846832085965Fracture Stem Reamer
00846832085958Fracture Stem Reamer
00846832085941Fracture Stem Reamer
00846832085934Fracture Stem Reamer
00846832085927Fracture Stem Reamer
00846832085910Fracture Stem Reamer
00846832085903Fracture Stem Reamer
00846832085897Fracture Stem Reamer
00846832085880Fracture Stem Reamer
00846832085873Fracture Stem Reamer
00846832085866Fracture Stem Reamer
00846832093663Fracture Reamers Case Base
00846832093656Fracture Revision Screw Caddy Lid
00846832093649Fracture Revision Screw Caddy Base
00846832093632Fracture Long Stem Case Base
00846832093625Fracture Screw Caddy Lid
00846832093618Fracture Screw Caddy Base
00846832093601Fracture JIG Case Base
00846832093595Fracture International Trials Case Base
00846832093588Fracture US Trials Case Base
00846832093571Fracture Instruments Case Base
00846832093564Fracture Case Lid
00846832086917Fracture Graft Clamp
00846832086634Fracture Height Gauge
00846832086351Fracture Rasp Extension
00846832086344Fracture Rasp Extension
00846832086337Fracture Rasp Extension
00846832086320Fracture Rasp Extension
00846832086313Fracture Rasp Extension
00846832086306Fracture Rasp Extension
00846832086290Fracture Rasp Extension
00846832086283Fracture Rasp Extension
00846832086276Fracture Rasp Extension
00846832086269Fracture Rasp Extension
00846832086252Fracture Rasp Extension
00846832086245Fracture Rasp Extension
00846832086238Fracture Rasp Extension
00846832086221Fracture Rasp Extension
00846832086214Fracture Rasp Extension
00846832086207Fracture Rasp Extension
00846832086191Fracture Rasp Metaphysis

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.