DEPUY INTERNATIONAL LTD

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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) (6) Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented (LZO) (3) Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented (KWY) (1) Prosthesis, hip, semi-constrained, metal/polymer, cemented (JDI) (1)

Premarket Exempt

No Yes

Clear

S-ROM - 10603295033141 Catalog Number : 136516500

Device Description : S-ROM M METAL ON METAL FEMORAL HEAD Diameter 28mm +0 12/14 TAPER ULTAMET

Device Class : 2

Duns Number: 896498813

Premarket Exempt : No

Product Code : JDI, KWY

Prescription Use : Yes

Device Count : 1

BIOLOX FORTE - 10603295034339 Catalog Number : 136576000

Device Description : BIOLOX FORTE CERAMIC FEMORAL HEAD +1 Diameter 32mm 12/14 TAPER

Device Class : 2

Duns Number: 896498813

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

BIOLOX FORTE - 10603295034346 Catalog Number : 136577000

Device Description : BIOLOX FORTE CERAMIC FEMORAL HEAD +5 Diameter 32mm 12/14 TAPER

Device Class : 2

Duns Number: 896498813

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

BIOLOX FORTE - 10603295034353 Catalog Number : 136578000

Device Description : BIOLOX FORTE CERAMIC FEMORAL HEAD +9 Diameter 32mm 12/14 TAPER

Device Class : 2

Duns Number: 896498813

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

AML - 10603295058311 Catalog Number : 155402000

Device Description : AML HIP SYSTEM FEMORAL STEM 12/14 TAPER HIP STEM 5/8 POROCOAT 10.5mm STD

Device Class : 2

Duns Number: 896498813

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

AML - 10603295058434 Catalog Number : 155403000

Device Description : AML HIP SYSTEM FEMORAL STEM 12/14 TAPER HIP STEM 5/8 POROCOAT 12.0mm STD

Device Class : 2

Duns Number: 896498813

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

AML - 10603295058519 Catalog Number : 155404000

Device Description : AML HIP SYSTEM FEMORAL STEM 12/14 TAPER HIP STEM 5/8 POROCOAT 13.5mm STD

Device Class : 2

Duns Number: 896498813

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

AML - 10603295058526 Catalog Number : 155405000

Device Description : AML HIP SYSTEM FEMORAL STEM 12/14 TAPER HIP STEM 5/8 POROCOAT 15.0mm STD

Device Class : 2

Duns Number: 896498813

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

AML - 10603295058533 Catalog Number : 155406000

Device Description : AML HIP SYSTEM FEMORAL STEM 12/14 TAPER HIP STEM 5/8 POROCOAT 16.5mm STD

Device Class : 2

Duns Number: 896498813

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

AML - 10603295058540 Catalog Number : 155407000

Device Description : AML HIP SYSTEM FEMORAL STEM 12/14 TAPER HIP STEM 5/8 POROCOAT 18.0mm STD

Device Class : 2

Duns Number: 896498813

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

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