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 - 04547898737442 Catalog Number : TJ41393-32

Device Description : STD-HO LINER TRIAL 40-56/58

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898737459 Catalog Number : TJ41393-36

Device Description : STD-HO LINER TRIAL 32-60/62/64

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898737466 Catalog Number : TJ41393-37

Device Description : STD-HO LINER TRIAL 36-60/62/64

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898737473 Catalog Number : TJ41393-38

Device Description : STD-HO LINER TRIAL 40-60/62/64

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898737480 Catalog Number : TJ41393-42

Device Description : STD-HO LINER TRIAL 32-66/68/70

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898737497 Catalog Number : TJ41393-43

Device Description : STD-HO LINER TRIAL 36-66/68/70

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898737503 Catalog Number : TJ41393-44

Device Description : STD-HO LINER TRIAL 40-66/68/70

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898737510 Catalog Number : TJ41393-49

Device Description : STD-HO LINER TRIAL 32-72/74

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898737527 Catalog Number : TJ41393-50

Device Description : STD-HO LINER TRIAL 36-72/74

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Initia Total Hip System - 04547898737534 Catalog Number : TJ41393-51

Device Description : STD-HO LINER TRIAL 40-72/74

Device Class : 2

Duns Number: 690557624

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

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