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) (5) Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented (KWY) (3) Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (LZO) (3) Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (LPH) (3) Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (HSD) (2) Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (KWT) (2)

Premarket Exempt

No Yes

Clear

SMR Shoulder - 08033390002561 Catalog Number : 1376.09.030

Device Description : Eccentrical Glenosphere

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390002592 Catalog Number : 1377.50.005

Device Description : Liner for metal-back (UHMWPE) Small-R

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390002608 Catalog Number : 1377.50.010

Device Description : Liner for metal-back (UHMWPE) Standard

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390002615 Catalog Number : 1377.50.020

Device Description : Liner for metal-back (UHMWPE) Small

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390002622 Catalog Number : 1377.50.030

Device Description : Liner for metal-back (UHMWPE) Large

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390002677 Catalog Number : 1378.50.010

Device Description : Cemented glenoids Standard

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWT, HSD

Prescription Use : Yes

Device Count : 1

SMR Shoulder - 08033390002684 Catalog Number : 1378.50.020

Device Description : Cemented glenoids Small

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWT, HSD

Prescription Use : Yes

Device Count : 1

REVISION - 08033390003841 Catalog Number : 3810.15.010

Device Description : Uncemented Stem Dia=14mm - L=140mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWY, LPH, LZO

Prescription Use : Yes

Device Count : 1

REVISION - 08033390003858 Catalog Number : 3810.15.020

Device Description : Uncemented Stem Dia=14mm - L=200mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : LZO, LPH, KWY

Prescription Use : Yes

Device Count : 1

REVISION - 08033390003865 Catalog Number : 3812.15.010

Device Description : Uncemented Stem Dia=16mm - L=140mm

Device Class : 2

Duns Number: 432066322

Premarket Exempt : No

Product Code : KWY, LPH, LZO

Prescription Use : Yes

Device Count : 1

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