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, Semi-Constrained, Metal/Polymer Cemented (KWS) (10) Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (HSD) (1)

Premarket Exempt

No Yes

Clear

SMR Shoulder - 08033390002066 Catalog Number : 1352.15.005

Device Description : Short reverse humeral body (inversion only)

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390002073 Catalog Number : 1352.15.010

Device Description : Reverse Humeral Body for Elective Surgery

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390002080 Catalog Number : 1352.15.050

Device Description : Finned reverse humeral body for trauma

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390002110 Catalog Number : 1352.15.200

Device Description : 36mm head adaptor for reverse humeral bodies

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : HSD, KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390002202 Catalog Number : 1360.50.820

Device Description : Reverse liners 36mm (UHMWPE) +6mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390002295 Catalog Number : 1374.09.105

Device Description : Glenosphere - Small-R

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390002301 Catalog Number : 1374.09.110

Device Description : Glenosphere

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390002332 Catalog Number : 1374.15.305

Device Description : Connector with screw Small-R

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390002349 Catalog Number : 1374.15.310

Device Description : Connector with screw Small-STD

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390002554 Catalog Number : 1376.09.025

Device Description : Eccentrical glenosphere - Small-R

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

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