KYOCERA CORPORATION

Address:6 Takeda Tobadono-cho, Fushimi-ku,Kyoto,JP

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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)

Premarket Exempt

No Yes

Clear

Initia Total Hip System - 04547898305016 Catalog Number : GMH02-500041

Device Description : INITIA STEM HO #5.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305023 Catalog Number : GMH02-500042

Device Description : INITIA STEM HO #6

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305030 Catalog Number : GMH02-500043

Device Description : INITIA STEM HO #6.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305047 Catalog Number : GMH02-500044

Device Description : INITIA STEM HO #7

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305054 Catalog Number : GMH02-500045

Device Description : INITIA STEM HO #8

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305061 Catalog Number : GMH02-500046

Device Description : INITIA STEM HO #9

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305078 Catalog Number : GMH02-500047

Device Description : INITIA STEM HO #10

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305085 Catalog Number : GMH02-500048

Device Description : INITIA STEM HO #11

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305092 Catalog Number : GMH03-400001

Device Description : METAL HEAD 22 +0

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305108 Catalog Number : GMH03-400002

Device Description : METAL HEAD 22 +3.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

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