Arthrex® AR-523-B513

GUDID 00888867232600

PS TIBIAL BEARING, SIZE 5, 13MM, VIT E

ARTHREX, INC.

Uncoated knee tibia/insert prosthesis
Primary Device ID00888867232600
NIH Device Record Key9d564178-90b9-4264-a3fa-a971dbcb5738
Commercial Distribution StatusIn Commercial Distribution
Brand NameArthrex®
Version Model NumberAR-523-B513
Catalog NumberAR-523-B513
Company DUNS131747628
Company NameARTHREX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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(800)934-4404
Emailcomplaints@arthrex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100888867232600 [Primary]
HIBCCM150AR523B5131 [Secondary]

FDA Product Code

MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-03-29
Device Publish Date2017-02-15

On-Brand Devices [Arthrex®]

10888867084008ANGEL cPRP PROCESSING SET US
10888867020808DISP INSTR. KIT FOR TENO SCRW
10888867018645DISPS KIT FOR 3X 8MM TENO
M150AR8942RLS1H-PLATE, 36 X 16MM RIGHT, LARGE, STRL
M150AR8942LMS1H-PLATE, 32 X 16MM, LEFT, MED, STRL
00888867020771IMPL SYS,LAT ANKLE RECON
00888867008786TIB OPEN WEDGE OSTEO PLATE, 17.5 MM
00888867008762TIB OPEN WEDGE OSTEO PLATE, 16 MM
00888867008724TIB OPEN WEDGE OSTEO PLATE, 13.5 MM
00888867008700TIB OPEN WEDGE OSTEO PLATE, 12.5 MM
00888867008663TIB OPEN WEDGE OSTEO PLATE, 10 MM
00888867008649TIB OPEN WEDGE OSTEO PLATE, 9 MM
00888867008625TIB OPEN WEDGE OSTEO PLATE, 7.5 MM
00888867008601TIB OPEN WEDGE OSTEO PLATE, 6 MM
00888867008588TIB OPEN WEDGE OSTEO PLATE, 5 MM
00888867007581FEM OPENG WEDG OSTEO PLT,12.5MM
00888867007543FEM OPENG WEDG OSTEO PLT,10MM
00888867007505FEM OPENG WEDG OSTEO PLT,7.5MM
M150AR8951LRS1LISFRANC PLATE, LARGE, RIGHT,TI, STRL
M150AR8951MRS1LISFRANC PLATE, MEDIUM,RIGHT,TI, STRL
M150AR8951SRS1LISFRANC PLATE, SMALL, RIGHT TI, STRL
M150AR8951LLS1LISFRANC PLATE, LARGE, LEFT, TI, STRL
M150AR8951MLS1LISFRANC PLATE, MEDIUM, LEFT,TI, STRL
M150AR8951SLS1LISFRANC PLATE, SMALL, LEFT, TI, STRL
0088886700960817.5 MM TIBIAL A/P SLOPED OSTEO PLATE
0088886700958516MM, TIBIAL A/P SLOPED OSTEOTOMY PLATE
0088886700956115 MM TIBIAL A/P SLOPED OSTEO PLATE
0088886700954713.5MMTIB A/P SLPD OSTEO PLT
0088886700952312.5 MM TIBIAL A/P SLOPED OSTEO PLATE
0088886700950911.0 MM TIBIAL A/P SLOPED OSTEO PLATE
008888670094629 MM TIBIAL A/P SLOPED OSTEO PLATE
008888670094487.5 MM TIBIAL A/P SLOPED OSTEO PLATE
008888670094246MM, TIBIAL A/P SLOPED OSTEOTOMY PLATE
008888670094005 MM TIBIAL A/P SLOPED OSTEO PLATE
M150AR700040FTS1CANN SCRW 3.75X 40MMFULLY THRDED, STRL
M150AR700028FTS1CANN SCRW,3.75X 28MMFULLY THRDED, STRL
M150AR700026FTS1CANN SCRW,3.75X 26MMFULLY THRDED, STRL
M150AR8916VNC34S12.4X34MM VAL NEAR CORTEX SCREW, Ti, STRL
M150AR8916VNC32S12.4X32MM VAL NEAR CORTEX SCREW, Ti, STRL
M150AR8916VNC30S12.4X30MM VAL NEAR CORTEX SCREW, Ti, STRL
M150AR8916VNC28S12.4X28MM VAL NEAR CORTEX SCREW, Ti, STRL
M150AR8916VNC26S12.4X26MM VAL NEAR CORTEX SCREW, Ti, STRL
M150AR8916VNC24S12.4X24MM VAL NEAR CORTEX SCREW, Ti, STRL
M150AR8916VNC22S12.4X22MM VAL NEAR CORTEX SCREW, Ti, STRL
M150AR8916VNC20S12.4X20MM VAL NEAR CORTEX SCREW, Ti, STRL
M150AR8916VNC18S12.4X18MM VAL NEAR CORTEX SCREW, Ti, STRL
M150AR8916VNC16S12.4X16MM VAL NEAR CORTEX SCREW, Ti, STRL
M150AR8916VNC14S12.4X14MM VAL NEAR CORTEX SCREW, Ti, STRL
M150AR8916VNC12S12.4X12MM VAL NEAR CORTEX SCREW, Ti, STRL
M150AR8916VNC10S12.4X10MM VAL NEAR CORTEX SCREW,Ti, STRL

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