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

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (HSD) (7) Shoulder Prosthesis, Reverse Configuration (PHX) (3)

Premarket Exempt

No Yes

Clear

Humelock II Cemented Reversible Shoulder - 03701037300299 Catalog Number : 105-4001

Device Description : HUMELOCK REVERSED ECCENTRIC GLENOSPHERE CoCr 10° TILT Ø40 mm

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : PHX

Prescription Use : No

Device Count : 1

Humelock II Cemented Reversible Shoulder - 03701037300305 Catalog Number : 105-4010

Device Description : HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø40 mm

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : PHX

Prescription Use : No

Device Count : 1

Humelock II Cemented Reversible Shoulder - 03701037300312 Catalog Number : 105-4011

Device Description : HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø40 mm

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : PHX

Prescription Use : No

Device Count : 1

Humelock Cemented Shoulder Prosthesis - 03701037300381 Catalog Number : 106-3914

Device Description : Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 39x14

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : HSD

Prescription Use : No

Device Count : 1

Humelock II Cemented Shoulder System - 03701037300398 Catalog Number : 106-4115

Device Description : CENTERED HEAD CrCo 41x15

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : HSD

Prescription Use : No

Device Count : 1

Humelock Cemented Shoulder Prosthesis - 03701037300404 Catalog Number : 106-4316

Device Description : Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 43x16

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : HSD

Prescription Use : No

Device Count : 1

Humelock Cemented Shoulder Prosthesis - 03701037300411 Catalog Number : 106-4617

Device Description : Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 46x17

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : HSD

Prescription Use : No

Device Count : 1

Humelock II Cemented Shoulder System - 03701037300428 Catalog Number : 106-4818

Device Description : CENTERED HEAD CrCo 48x18

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : HSD

Prescription Use : No

Device Count : 1

Humelock Cemented Shoulder Prosthesis - 03701037300435 Catalog Number : 106-5019

Device Description : Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 50x19

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : HSD

Prescription Use : No

Device Count : 1

Humelock II Cemented Shoulder System - 03701037300442 Catalog Number : 106-5420

Device Description : CENTERED HEAD CrCo 54x20

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

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