FX V135 Shoulder Prosthesis

GUDID 03701037317044

OFFSET HEAD 43x15

FX SOLUTIONS

Stem-fixed humeral head prosthesis
Primary Device ID03701037317044
NIH Device Record Keya8431a03-f0c2-4cea-99ec-ad048d2dcfd1
Commercial Distribution StatusIn Commercial Distribution
Brand NameFX V135 Shoulder Prosthesis
Version Model Number206-4332
Company DUNS263076196
Company NameFX SOLUTIONS
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103701037317044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PHXShoulder Prosthesis, Reverse Configuration

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-31
Device Publish Date2024-01-23

On-Brand Devices [FX V135 Shoulder Prosthesis]

03701037315408203-0906 FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø36 +6
03701037315392FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø36 +3
03701037315385FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø32 +9
03701037315378FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø32 +6
03701037315361FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø32 +3
03701037315323FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +9
03701037315316FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +6
03701037315309FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +3
03701037315293FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +9
03701037315286FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +6
03701037315279FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +3
03701037317174OFFSET HEAD 50x22
03701037317167OFFSET HEAD 50x18
03701037317150CENTERED HEAD 50x21
03701037317143CENTERED HEAD 50x17
03701037317136OFFSET HEAD 48x21
03701037317129OFFSET HEAD 48x17
03701037317112CENTERED HEAD 48x20
03701037317105CENTERED HEAD 48x16
03701037317099OFFSET HEAD 46x20
03701037317082OFFSET HEAD 46x16
03701037317075CENTERED HEAD 46x19
03701037317068CENTERED HEAD 46x15
03701037317051OFFSET HEAD 43x19
03701037317044OFFSET HEAD 43x15
03701037317037CENTERED HEAD 43x18
03701037317020CENTERED HEAD 43x14
03701037317013OFFSET HEAD 41x18
03701037317006OFFSET HEAD 41x14
03701037316993CENTERED HEAD 41x17
03701037316986CENTERED HEAD 41x13
03701037316979OFFSET HEAD 39x17
03701037316962OFFSET HEAD 39x13
03701037316955CENTERED HEAD 39x16
03701037316948CENTERED HEAD 39x13
03701037315446FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +9
03701037315439FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +6
03701037315422FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +3
03701037315415FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø36 +9
03701037315354FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +9
03701037315347FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +6
03701037315330FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +3
03701037320396Glenoid Manual Reamer Ø36mm
03701037320389Glenoid Manual Reamer Ø40mm
03701037318973FX V135 PLATE FOR CUPULAR ROLE SAW
03701037318966INLAY CUP HOLE SAW Ø36mm

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