DEPUY (IRELAND)

Address:LOUGHBEG,CO. CORK Munster,IE

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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, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED (LPH) (10) Prosthesis, hip, semi-constrained, metal/polymer, cemented (JDI) (10) PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER (KRO) (2) PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER (JWH) (2) Prosthesis, hip, semi-constrained (metal uncemented acetabular component) (KWA) (2) Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented (LZO) (2)

Premarket Exempt

No Yes

Clear

PINNACLE GRIPTION - 10603295010135 Catalog Number : 121730466

Device Description : PINNACLE GRIPTION TF ACETABULAR REVISION AUGMENT 30mm 66/68mm

Device Class : 2

Duns Number: 989365556

Premarket Exempt : No

Product Code : KWA, JDI, LPH, LZO, KRO, JWH

Prescription Use : Yes

Device Count : 1

PINNACLE GRIPTION - 10603295010142 Catalog Number : 121730470

Device Description : PINNACLE GRIPTION TF ACETABULAR REVISION AUGMENT 30mm 70/72mm

Device Class : 2

Duns Number: 989365556

Premarket Exempt : No

Product Code : JWH, KRO, JDI, KWA, LZO, LPH

Prescription Use : Yes

Device Count : 1

DURALOC - 10603295019589 Catalog Number : 124580049

Device Description : DURALOC SHELL SECTOR 52mm OD CEMENTLESS

Device Class : 2

Duns Number: 989365556

Premarket Exempt : No

Product Code : JDI, LPH

Prescription Use : Yes

Device Count : 1

DURALOC - 10603295019596 Catalog Number : 124580050

Device Description : DURALOC SHELL SECTOR 54mm OD CEMENTLESS

Device Class : 2

Duns Number: 989365556

Premarket Exempt : No

Product Code : LPH, JDI

Prescription Use : Yes

Device Count : 1

DURALOC - 10603295019602 Catalog Number : 124580051

Device Description : DURALOC SHELL SECTOR 56mm OD CEMENTLESS

Device Class : 2

Duns Number: 989365556

Premarket Exempt : No

Product Code : LPH, JDI

Prescription Use : Yes

Device Count : 1

DURALOC - 10603295019619 Catalog Number : 124580052

Device Description : DURALOC SHELL SECTOR 58mm OD CEMENTLESS

Device Class : 2

Duns Number: 989365556

Premarket Exempt : No

Product Code : LPH, JDI

Prescription Use : Yes

Device Count : 1

DURALOC - 10603295019626 Catalog Number : 124580053

Device Description : DURALOC SHELL SECTOR 60mm OD CEMENTLESS

Device Class : 2

Duns Number: 989365556

Premarket Exempt : No

Product Code : JDI, LPH

Prescription Use : Yes

Device Count : 1

DURALOC - 10603295019633 Catalog Number : 124580054

Device Description : DURALOC SHELL SECTOR 62mm OD CEMENTLESS

Device Class : 2

Duns Number: 989365556

Premarket Exempt : No

Product Code : LPH, JDI

Prescription Use : Yes

Device Count : 1

DURALOC - 10603295019640 Catalog Number : 124580055

Device Description : DURALOC SHELL SECTOR 48mm OD CEMENTLESS

Device Class : 2

Duns Number: 989365556

Premarket Exempt : No

Product Code : LPH, JDI

Prescription Use : Yes

Device Count : 1

DURALOC - 10603295019657 Catalog Number : 124580056

Device Description : DURALOC SHELL SECTOR 50mm OD CEMENTLESS

Device Class : 2

Duns Number: 989365556

Premarket Exempt : No

Product Code : JDI, LPH

Prescription Use : Yes

Device Count : 1

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