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) (6) Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (HSD) (4) Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (KWT) (1)

Premarket Exempt

No Yes

Clear

Humelock II Cemented Shoulder System - 03701037300732 Catalog Number : 112-0000

Device Description : DOUBLE TAPER TA6V +0 mm 0°

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : HSD

Prescription Use : No

Device Count : 1

Humeris Shoulder - 03701037300749 Catalog Number : 112-0030

Device Description : DOUBLE TAPER TA6V +0 mm +/-3°

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

Humeris Shoulder - 03701037300756 Catalog Number : 112-0033

Device Description : DOUBLE TAPER TA6V +3 mm +/-3°

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

Humeris Shoulder - 03701037300763 Catalog Number : 112-0035

Device Description : DOUBLE TAPER TA6V +5 mm +/-3°

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

Humelock II Cemented Reversible Shoulder - 03701037300770 Catalog Number : 112-0100

Device Description : REVERSED ADAPTER TA6V 135/145°

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : PHX

Prescription Use : No

Device Count : 1

TiN Coated Glenosphere - 03701037300800 Catalog Number : 115-3610

Device Description : HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V/TiN 10° TILT Ø36mm

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : PHX

Prescription Use : No

Device Count : 1

TiN Coated Glenosphere - 03701037300817 Catalog Number : 115-3613

Device Description : HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW COCR/TA6V/TiN 10° TILT Ø36mm

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : PHX

Prescription Use : No

Device Count : 1

TiN Coated Glenosphere - 03701037300848 Catalog Number : 115-4010

Device Description : HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V/TiN 10° TILT Ø40mm

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : PHX

Prescription Use : No

Device Count : 1

TiN Coated Glenosphere - 03701037300855 Catalog Number : 115-4011

Device Description : HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW COCR/TA6V/TiN 10° TILT Ø40mm

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : PHX

Prescription Use : No

Device Count : 1

TiN Coated Humeral Head - 03701037300879 Catalog Number : 116-3914

Device Description : CENTERED HEAD CoCr/TiN 39x14

Device Class : 2

Duns Number: 263076196

Premarket Exempt : No

Product Code : PHX, KWT

Prescription Use : Yes

Device Count : 1

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