LIMACORPORATE SPA

Address:Via Nazionale 52,Villanova di San Daniele Udine,IT

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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) (10) Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (KWT) (6) Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (KWS) (4)

Premarket Exempt

No Yes

Clear

SMR Shoulder - 08033390000987 Catalog Number : 1304.15.240

Device Description : Finned humeral stems - 80mm (Ti6Al4V) dia.24mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : HSD, KWT

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390000994 Catalog Number : 1306.15.120

Device Description : Cemented humeral stems L.80mm dia.12mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWT, HSD

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390001007 Catalog Number : 1306.15.140

Device Description : Cemented humeral stems L.80mm dia.14mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWT, HSD

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390001014 Catalog Number : 1306.15.160

Device Description : Cemented humeral stems L.80mm dia.16mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWT, HSD

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390001021 Catalog Number : 1306.15.180

Device Description : Cemented humeral stems L.80mm dia.18mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWT, HSD

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390001038 Catalog Number : 1306.15.200

Device Description : Cemented humeral stems L.80mm dia.20mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWT, HSD

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390001045 Catalog Number : 1308.15.134

Device Description : Uncemented revision stems (Ti6Al4V) dia.13mm, h.150mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS, HSD

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390001052 Catalog Number : 1308.15.136

Device Description : Uncemented revision stems (Ti6Al4V) dia.13mm, h.180mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : HSD, KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390001069 Catalog Number : 1308.15.144

Device Description : Uncemented revision stems (Ti6Al4V) dia.14mm, h.150mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS, HSD

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390001076 Catalog Number : 1308.15.146

Device Description : Uncemented revision stems (Ti6Al4V) dia.14mm, h.180mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : HSD, KWS

Prescription Use : Yes

Device Count : 1

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