Legion E0017110-8

GUDID 00885556793930

OVERSIZED FIN PUNCH TIBIAL TRIAL SZ 2 R

Smith & Nephew, Inc.

Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial
Primary Device ID00885556793930
NIH Device Record Key05547db5-b8e2-4513-91f6-885bfddc900c
Commercial Distribution StatusIn Commercial Distribution
Brand NameLegion
Version Model NumberE0017110-8
Catalog NumberE0017110-8
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
GS100885556793930 [Primary]
GS100885556793930 [Primary]
GS100885556793930 [Primary]
GS100885556793930 [Primary]
GS100885556793930 [Primary]
GS100885556793930 [Primary]
GS100885556793930 [Primary]
GS100885556793930 [Primary]
GS100885556793930 [Primary]
GS100885556793930 [Primary]
GS100885556793930 [Primary]
GS100885556793930 [Primary]
GS100885556793930 [Primary]
GS100885556793930 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556793930]

Moist Heat or Steam Sterilization


[00885556793930]

Moist Heat or Steam Sterilization


[00885556793930]

Moist Heat or Steam Sterilization


[00885556793930]

Moist Heat or Steam Sterilization


[00885556793930]

Moist Heat or Steam Sterilization


[00885556793930]

Moist Heat or Steam Sterilization


[00885556793930]

Moist Heat or Steam Sterilization


[00885556793930]

Moist Heat or Steam Sterilization


[00885556793930]

Moist Heat or Steam Sterilization


[00885556793930]

Moist Heat or Steam Sterilization


[00885556793930]

Moist Heat or Steam Sterilization


[00885556793930]

Moist Heat or Steam Sterilization


[00885556793930]

Moist Heat or Steam Sterilization


[00885556793930]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-04

On-Brand Devices [Legion]

00885556741764CAPTURELESS MIS AP CUTTING BLOCK SZ-8
00885556741757CAPTURELESS MIS AP CUTTING BLOCK SZ-7
00885556741740CAPTURELESS MIS AP CUTTING BLOCK SZ-6
00885556741733CAPTURELESS MIS AP CUTTING BLOCK SZ-5
00885556741726CAPTURELESS MIS AP CUTTING BLOCK SZ-4
00885556741702CAPTURELESS MIS AP CUTTING BLOCK SZ-3
008855567413992MM RECUT BLOCK
008855567413822MM SHIM
00885556741351STATIC FEMORAL LUG DRILL
00885556741085HANDLE
0088555674107811MM TIBIAL TRIAL STEM PLUG SZ. 7-8 RIGHT
0088555674106111MM TIBIAL TRIAL STEM PLUG SZ. 5-6 RIGHT
0088555674105411MM TIBIAL TRIAL STEM PLUG SZ. 3-4 RIGHT
0088555674104711MM TIBIAL TRIAL STEM PLUG SZ. 7-8 LEFT
0088555674103011MM TIBIAL TRIAL STEM PLUG SZ. 5-6 LEFT
0088555674102311MM TIBIAL TRIAL STEM PLUG SZ. 3-4 LEFT
00885556741016TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 8 RIGHT
00885556741009TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 7 RIGHT
00885556740996TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 6 RIGHT
00885556740989TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 5 RIGHT
00885556740972TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 4 RIGHT
00885556740965TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 3 RIGHT
00885556740958TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 8 LEFT
00885556740941TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 7 LEFT
00885556740934TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 6 LEFT
00885556740927TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 5 LEFT
00885556740910TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 4 LEFT
00885556740903TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 3 LEFT
008855567408352 DEG. VARUS/VALGUS RECUT BLOCK
008855567406510 DEGREE MIS TIBIA CUTTING BLOCK - RIGHT
008855567406440 DEGREE MIS TIBIA CUTTING BLOCK - LEFT
008855567399692MM RECUT BLOCK
00885556739914LEGION MIS CUTTING BLOCK SZ 8
00885556739907LEGION MIS CUTTING BLOCK SZ 7
00885556739891LEGION MIS CUTTING BLOCK SZ 6
00885556739884LEGION MIS CUTTING BLOCK SZ 5
00885556739877LEGION MIS CUTTING BLOCK SZ 4
00885556739860LEGION MIS CUTTING BLOCK SZ 3
00885556739853BOX COLLET WITH SOLID SCREW SZ 6
00885556739839GII MIS PATELLA PROTECTIVE CAP 41MM
00885556739822GII MIS PATELLA PROTECTIVE CAP 38MM
00885556739815GII MIS PATELLA PROTECTIVE CAP 35MM
00885556739792GII MIS PATELLA PROTECTIVE CAP 32MM
00885556739785GII MIS PATELLA PROTECTIVE CAP 29MM
00885556739761AP CUTTING BLOCK - SZ 7
00885556739754AP CUTTING BLOCK - SZ 4
00885556739747FLEXIBLE IM ROD
00885556739266MIS AP 4-IN-1 BLOCK W/SHORT SPIKES SZ 8
00885556739259MIS AP 4-IN-1 BLOCK W/SHORT SPIKES SZ 7
00885556739242MIS AP 4-IN-1 BLOCK W/SHORT SPIKES SZ 6

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