FX SOLUTIONS

Address:1663 rue de Majornas,Viriat Auvergne-Rhone-Alpes,FR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Shoulder Prosthesis, Reverse Configuration (PHX) (7) Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (HSD) (2) Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (KWT) (2)

Premarket Exempt

No Yes

Clear

Humelock Reversed Shoulder - 03701037300084 Catalog Number : 103-0007

Device Description : HUMERAL SPACER TA6V +9 mm

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

Humelock II Cemented Reversible Shoulder - 03701037300091 Catalog Number : 103-0803

Device Description : HUMERAL CUP STANDARD PE/TA6V Ø36/+3

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : PHX

Prescription Use : No

Device Count : 1

Humelock II Cemented Reversible Shoulder - 03701037300107 Catalog Number : 103-0806

Device Description : HUMERAL CUP STANDARD PE/TA6V Ø36/+6

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : PHX

Prescription Use : No

Device Count : 1

Humelock II Cemented Reversible Shoulder - 03701037300114 Catalog Number : 103-0809

Device Description : HUMERAL CUP STANDARD PE/TA6V Ø36/+9

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : PHX

Prescription Use : No

Device Count : 1

Humelock II Cemented Reversible Shoulder - 03701037300121 Catalog Number : 104-0803

Device Description : HUMERAL CUP STANDARD PE/TA6V Ø40/+3

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : PHX

Prescription Use : No

Device Count : 1

Humelock II Cemented Reversible Shoulder - 03701037300138 Catalog Number : 104-0806

Device Description : HUMERAL CUP STANDARD PE/TA6V Ø40/+6

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : PHX

Prescription Use : No

Device Count : 1

Humelock II Cemented Reversible Shoulder - 03701037300145 Catalog Number : 104-0809

Device Description : HUMERAL CUP STANDARD PE/TA6V Ø40/+9

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : PHX

Prescription Use : No

Device Count : 1

Humelock Reversed Shoulder - 03701037300152 Catalog Number : 105-0000

Device Description : ECCENTRIC TAPER ADAPTER TA6V Ø24 / Ø10

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : HSD, PHX

Prescription Use : Yes

Device Count : 1

Humelock II Cemented Shoulder System - 03701037300169 Catalog Number : 105-0001

Device Description : 2 PEGS GLENOID PE CEMENTED SIZE XS

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : KWT

Prescription Use : No

Device Count : 1

Humelock II Cemented Shoulder System - 03701037300176 Catalog Number : 105-0002

Device Description : 2 PEGS GLENOID PE CEMENTED SIZE S

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : KWT

Prescription Use : No

Device Count : 1

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