Journey E0017063-7

GUDID 00885556790991

JOURNEY CHAMFER BLOCK - SIZE 8

Smith & Nephew, Inc.

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID00885556790991
NIH Device Record Key37938ea6-a5a6-4f76-afe7-342c17062cc5
Commercial Distribution StatusIn Commercial Distribution
Brand NameJourney
Version Model NumberE0017063-7
Catalog NumberE0017063-7
Company DUNS109903521
Company NameSmith & Nephew, 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 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)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556790991 [Primary]
GS100885556790991 [Primary]
GS100885556790991 [Primary]
GS100885556790991 [Primary]
GS100885556790991 [Primary]
GS100885556790991 [Primary]
GS100885556790991 [Primary]
GS100885556790991 [Primary]
GS100885556790991 [Primary]
GS100885556790991 [Primary]
GS100885556790991 [Primary]
GS100885556790991 [Primary]
GS100885556790991 [Primary]
GS100885556790991 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556790991]

Moist Heat or Steam Sterilization


[00885556790991]

Moist Heat or Steam Sterilization


[00885556790991]

Moist Heat or Steam Sterilization


[00885556790991]

Moist Heat or Steam Sterilization


[00885556790991]

Moist Heat or Steam Sterilization


[00885556790991]

Moist Heat or Steam Sterilization


[00885556790991]

Moist Heat or Steam Sterilization


[00885556790991]

Moist Heat or Steam Sterilization


[00885556790991]

Moist Heat or Steam Sterilization


[00885556790991]

Moist Heat or Steam Sterilization


[00885556790991]

Moist Heat or Steam Sterilization


[00885556790991]

Moist Heat or Steam Sterilization


[00885556790991]

Moist Heat or Steam Sterilization


[00885556790991]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

On-Brand Devices [Journey]

00885556741535LOW PROFILE CEMENT CLAMP
00885556740866PATELLA RESECTION GUIDE
00885556740828FLEXIBLE IM ROD
00885556740811ANTERIOR FEMORAL CUTTING BLOCK
00885556740804DISTAL FEMORAL RESECTION CHECK
00885556740798DISTAL ALIGNMENT GUIDE - RIGHT
00885556740781DISTAL ALIGNMENT GUIDE - LEFT
00885556740774DISTAL RESECTION BLOCK - RIGHT
00885556740767DISTAL RESECTION BLOCK - LEFT
00885556740750DISTAL ALIGNMENT OFFSET ROD - RIGHT
00885556740743DISTAL ALIGNMENT OFFSET ROD - LEFT
00885556740736NEUTRAL DISTAL ALIGNMENT OFFSET ROD
00885556737705FEMORAL SIZING GUIDE - RIGHT
00885556737699FEMORAL SIZING GUIDE - LEFT
00885556737682TIBIA CUTTING BLOCK - RIGHT
00885556737675TIBIA CUTTING BLOCK - LEFT
00885556737668FEMORAL SIZING STYLUS
00885556735923ADJUSTABLE TIBIA STYLUS
008855567191692MM RECUT BLOCK
00885556714539SIZING GUIDE WITH SHORT PADDLES - RIGHT
00885556714522SIZING GUIDE WITH SHORT PADDLES - LEFT
00885556713419MODIFIED TIBIAL ALIGNMENT TUBE
008855567075552MM RECUT BLOCK
00885556697733FEMORAL NOTCH PREP GUIDE SZ 9~10
00885556697726FEMORAL NOTCH PREP GUIDE SZ 6~8
00885556697719FEMORAL NOTCH PREP GUIDE SZ 3~5
00885556697702FEMORAL NOTCH PREP GUIDE SZ 1~2
00885556697696BUMPER 9-10 R
00885556697689BUMPER 9-10 L
00885556697672BUMPER 1-8 R
00885556697665BUMPER 1-8 L
00885556697658JOURNEY CR FEMORAL IMPACTOR
00885556697450FLEXIBLE IM ROD
00885556697405NO ROTATION JOURNEY SIZING STYLUS
00885556697146LOW PROFILE DONUT PATELLA CLAMP
00885556694176JOURNEY RESURFACING PATELLAR DRILL
00885556693087RIGHT TISSUE SPARING POSTERIOR PADDLES
00885556693070LEFT TISSUE SPARING POSTERIOR PADDLES
00885556692677JOURNEY LOCKING TIBIAL IMPACTOR
00885556692325RIGHT MODIFIED TIBIAL CUTTING BLOCK
00885556692318LEFT MODIFIED TIBIAL CUTTING BLOCK
00885556689899PATELLA DRILL GUIDE 38-41MM
00885556689882PATELLA DRILL GUIDE 32-35MM
00885556689875PATELLA DRILL GUIDE 26-29MM
00885556689868PATELLA CLAMP LEVER
00885556689196TIBIAL TRIAL INSERT FORK HANDLE
00885556687413XR ANTERIOR EMINENCE CHISEL GUIDE LONG
00885556685990TIBIAL STYLUS WITH SPRING FOOT 2MM/9MM
00885556685983NONSLOTTED 3 DEG TIBIA BLOCK RIGHT
00885556685976NONSLOTTED 3 DEG TIBIA BLOCK LEFT

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