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 - 04547898305313 Catalog Number : GMH03-400023

Device Description : METAL HEAD 40 +3.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305320 Catalog Number : GMH03-400024

Device Description : METAL HEAD 40 +7

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305337 Catalog Number : GMH03-400025

Device Description : METAL HEAD 40 +10.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305344 Catalog Number : GMH03-400026

Device Description : METAL HEAD 44 -3.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305351 Catalog Number : GMH03-400027

Device Description : METAL HEAD 44 +0

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305368 Catalog Number : GMH03-400028

Device Description : METAL HEAD 44 +3.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305375 Catalog Number : GMH03-400029

Device Description : METAL HEAD 44 +7

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305382 Catalog Number : GMH03-400030

Device Description : METAL HEAD 44 +10.5

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305399 Catalog Number : GMH02-100001

Device Description : INITIA SHELL 40-5H

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898305405 Catalog Number : GMH02-100002

Device Description : INITIA SHELL 42-5H

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

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