KYOCERA MEDICAL TECHNOLOGIES, INC.

Address:1200 California Street,Redlands,CA,92374,US

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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

Orthopedic Manual Surgical Instrument (LXH) (10)

Premarket Exempt

Yes No

Clear

Kyocera Medical Technologies, Inc. - 00841523157624 Catalog Number : 2168-331-613

Device Description : Tesera-k ALIF, 31W X 26D, 13mm, 22° Broach

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523157631 Catalog Number : 2168-331-615

Device Description : Tesera-k ALIF, 31W X 26D, 15mm, 22° Broach

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523157648 Catalog Number : 2168-331-617

Device Description : Tesera-k ALIF, 31W X 26D, 17mm, 22° Broach

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523157655 Catalog Number : 2168-331-619

Device Description : Tesera-k ALIF, 31W X 26D, 19mm, 22° Broach

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523157662 Catalog Number : 2168-331-621

Device Description : Tesera-k ALIF, 31W X 26D, 21mm, 22° Broach

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523157679 Catalog Number : 2168-334-815

Device Description : Tesera-k ALIF, 34W X 28D, 15mm, 22° Broach

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523157686 Catalog Number : 2168-334-817

Device Description : Tesera-k ALIF, 34W X 28D, 17mm, 22° Broach

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523157693 Catalog Number : 2168-334-819

Device Description : Tesera-k ALIF, 34W X 28D, 19mm, 22° Broach

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523157709 Catalog Number : 2168-334-821

Device Description : Tesera-k ALIF, 34W X 28D, 21mm, 22° Broach

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523157716 Catalog Number : 2168-338-015

Device Description : Tesera-k ALIF, 38W X 30D, 15mm, 22° Broach

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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