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 - 04547898305412 Catalog Number : GMH02-100003

Device Description : INITIA SHELL 44-5H

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305429 Catalog Number : GMH02-100004

Device Description : INITIA SHELL 46-7H

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305436 Catalog Number : GMH02-100005

Device Description : INITIA SHELL 48-7H

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305443 Catalog Number : GMH02-100006

Device Description : INITIA SHELL 50-7H

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305450 Catalog Number : GMH02-100007

Device Description : INITIA SHELL 52-7H

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305467 Catalog Number : GMH02-100008

Device Description : INITIA SHELL 54-7H

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305474 Catalog Number : GMH02-100009

Device Description : INITIA SHELL 56-7H

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305481 Catalog Number : GMH02-100010

Device Description : INITIA SHELL 58-7H

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305498 Catalog Number : GMH02-100011

Device Description : INITIA SHELL 60-7H

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305504 Catalog Number : GMH02-100012

Device Description : INITIA SHELL 62-7H

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

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