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

Premarket Exempt

No Yes

Clear

SMR Shoulder - 08033390001083 Catalog Number : 1308.15.154

Device Description : Uncemented revision stems (Ti6Al4V) dia.15mm, h.150mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS, HSD

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390001090 Catalog Number : 1308.15.156

Device Description : Uncemented revision stems (Ti6Al4V) dia.15mm, h.180mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : HSD, KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390001106 Catalog Number : 1308.15.164

Device Description : Uncemented revision stems (Ti6Al4V) dia.16mm, h.150mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS, HSD

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390001113 Catalog Number : 1308.15.166

Device Description : Uncemented revision stems (Ti6Al4V) dia.16mm, h.180mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : HSD, KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390001274 Catalog Number : 1317.15.010

Device Description : Resurfacing stems (Ti6Al4V) 11 x 32mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS, HSD

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390001281 Catalog Number : 1317.15.020

Device Description : Resurfacing stems (Ti6Al4V) 13 x 36mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : HSD, KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390001373 Catalog Number : 1322.09.420

Device Description : Humeral heads (CoCrMo) dia.42mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWT, HSD

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390001380 Catalog Number : 1322.09.440

Device Description : Humeral heads (CoCrMo) dia.44mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWT, HSD

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390001397 Catalog Number : 1322.09.460

Device Description : Humeral heads (CoCrMo) dia.46mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWT, HSD

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390001403 Catalog Number : 1322.09.480

Device Description : Humeral heads (CoCrMo) dia.48mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWT, HSD

Prescription Use : Yes

Device Count : 1

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