KYOCERA CORPORATION

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 - 04547898304712 Catalog Number : GMH02-500011

Device Description : INITIA STEM STD #0

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898304729 Catalog Number : GMH02-500012

Device Description : INITIA STEM STD #0.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898304736 Catalog Number : GMH02-500013

Device Description : INITIA STEM STD #1

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898304743 Catalog Number : GMH02-500014

Device Description : INITIA STEM STD #1.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898304750 Catalog Number : GMH02-500015

Device Description : INITIA STEM STD #2

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898304767 Catalog Number : GMH02-500016

Device Description : INITIA STEM STD #2.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898304774 Catalog Number : GMH02-500017

Device Description : INITIA STEM STD #3

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898304781 Catalog Number : GMH02-500018

Device Description : INITIA STEM STD #3.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898304798 Catalog Number : GMH02-500019

Device Description : INITIA STEM STD #4

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898304804 Catalog Number : GMH02-500020

Device Description : INITIA STEM STD #4.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

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