Arthrex® AR-9100-08F

GUDID 00888867057074

UNIVERS FRACTURE STEM, 8MM

ARTHREX, INC.

Total shoulder prosthesis

• Primary Device ID: 00888867057074
• NIH Device Record Key: 6e81897c-b518-4357-adbf-07158814093c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arthrex®
• Version Model Number: AR-9100-08F
• Catalog Number: AR-9100-08F
• Company DUNS: 131747628
• Company Name: ARTHREX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888867057074 [Primary]
HIBCC	M150AR910008F2 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020345

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-08-14
• Device Publish Date: 2017-02-15

On-Brand Devices [Arthrex®]

• 10888867084008: ANGEL cPRP PROCESSING SET US
• 10888867020808: DISP INSTR. KIT FOR TENO SCRW
• 10888867018645: DISPS KIT FOR 3X 8MM TENO
• M150AR8942RLS1: H-PLATE, 36 X 16MM RIGHT, LARGE, STRL
• M150AR8942LMS1: H-PLATE, 32 X 16MM, LEFT, MED, STRL
• 00888867020771: IMPL SYS,LAT ANKLE RECON
• 00888867008786: TIB OPEN WEDGE OSTEO PLATE, 17.5 MM
• 00888867008762: TIB OPEN WEDGE OSTEO PLATE, 16 MM
• 00888867008724: TIB OPEN WEDGE OSTEO PLATE, 13.5 MM
• 00888867008700: TIB OPEN WEDGE OSTEO PLATE, 12.5 MM
• 00888867008663: TIB OPEN WEDGE OSTEO PLATE, 10 MM
• 00888867008649: TIB OPEN WEDGE OSTEO PLATE, 9 MM
• 00888867008625: TIB OPEN WEDGE OSTEO PLATE, 7.5 MM
• 00888867008601: TIB OPEN WEDGE OSTEO PLATE, 6 MM
• 00888867008588: TIB OPEN WEDGE OSTEO PLATE, 5 MM
• 00888867007581: FEM OPENG WEDG OSTEO PLT,12.5MM
• 00888867007543: FEM OPENG WEDG OSTEO PLT,10MM
• 00888867007505: FEM OPENG WEDG OSTEO PLT,7.5MM
• M150AR8951LRS1: LISFRANC PLATE, LARGE, RIGHT,TI, STRL
• M150AR8951MRS1: LISFRANC PLATE, MEDIUM,RIGHT,TI, STRL
• M150AR8951SRS1: LISFRANC PLATE, SMALL, RIGHT TI, STRL
• M150AR8951LLS1: LISFRANC PLATE, LARGE, LEFT, TI, STRL
• M150AR8951MLS1: LISFRANC PLATE, MEDIUM, LEFT,TI, STRL
• M150AR8951SLS1: LISFRANC PLATE, SMALL, LEFT, TI, STRL
• 00888867009608: 17.5 MM TIBIAL A/P SLOPED OSTEO PLATE
• 00888867009585: 16MM, TIBIAL A/P SLOPED OSTEOTOMY PLATE
• 00888867009561: 15 MM TIBIAL A/P SLOPED OSTEO PLATE
• 00888867009547: 13.5MMTIB A/P SLPD OSTEO PLT
• 00888867009523: 12.5 MM TIBIAL A/P SLOPED OSTEO PLATE
• 00888867009509: 11.0 MM TIBIAL A/P SLOPED OSTEO PLATE
• 00888867009462: 9 MM TIBIAL A/P SLOPED OSTEO PLATE
• 00888867009448: 7.5 MM TIBIAL A/P SLOPED OSTEO PLATE
• 00888867009424: 6MM, TIBIAL A/P SLOPED OSTEOTOMY PLATE
• 00888867009400: 5 MM TIBIAL A/P SLOPED OSTEO PLATE
• M150AR700040FTS1: CANN SCRW 3.75X 40MMFULLY THRDED, STRL
• M150AR700028FTS1: CANN SCRW,3.75X 28MMFULLY THRDED, STRL
• M150AR700026FTS1: CANN SCRW,3.75X 26MMFULLY THRDED, STRL
• M150AR8916VNC34S1: 2.4X34MM VAL NEAR CORTEX SCREW, Ti, STRL
• M150AR8916VNC32S1: 2.4X32MM VAL NEAR CORTEX SCREW, Ti, STRL
• M150AR8916VNC30S1: 2.4X30MM VAL NEAR CORTEX SCREW, Ti, STRL
• M150AR8916VNC28S1: 2.4X28MM VAL NEAR CORTEX SCREW, Ti, STRL
• M150AR8916VNC26S1: 2.4X26MM VAL NEAR CORTEX SCREW, Ti, STRL
• M150AR8916VNC24S1: 2.4X24MM VAL NEAR CORTEX SCREW, Ti, STRL
• M150AR8916VNC22S1: 2.4X22MM VAL NEAR CORTEX SCREW, Ti, STRL
• M150AR8916VNC20S1: 2.4X20MM VAL NEAR CORTEX SCREW, Ti, STRL
• M150AR8916VNC18S1: 2.4X18MM VAL NEAR CORTEX SCREW, Ti, STRL
• M150AR8916VNC16S1: 2.4X16MM VAL NEAR CORTEX SCREW, Ti, STRL
• M150AR8916VNC14S1: 2.4X14MM VAL NEAR CORTEX SCREW, Ti, STRL
• M150AR8916VNC12S1: 2.4X12MM VAL NEAR CORTEX SCREW, Ti, STRL
• M150AR8916VNC10S1: 2.4X10MM VAL NEAR CORTEX SCREW,Ti, STRL