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 - 04547898304910 Catalog Number : GMH02-500031

Device Description : INITIA STEM HO #0.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898304927 Catalog Number : GMH02-500032

Device Description : INITIA STEM HO #1

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898304934 Catalog Number : GMH02-500033

Device Description : INITIA STEM HO #1.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898304941 Catalog Number : GMH02-500034

Device Description : INITIA STEM HO #2

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898304958 Catalog Number : GMH02-500035

Device Description : INITIA STEM HO #2.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898304965 Catalog Number : GMH02-500036

Device Description : INITIA STEM HO #3

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898304972 Catalog Number : GMH02-500037

Device Description : INITIA STEM HO #3.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898304989 Catalog Number : GMH02-500038

Device Description : INITIA STEM HO #4

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898304996 Catalog Number : GMH02-500039

Device Description : INITIA STEM HO #4.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305009 Catalog Number : GMH02-500040

Device Description : INITIA STEM HO #5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

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