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) (9)

Premarket Exempt

No Yes

Clear

Kyocera Medical Technologies, Inc. - 00841523158300 Catalog Number : 2168-434-821

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

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523158317 Catalog Number : 2168-438-019

Device Description : Tesera-k ALIF, 38W X 30D, 19mm, 28° Broach

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523158324 Catalog Number : 2168-438-021

Device Description : Tesera-k ALIF, 38W X 30D, 21mm, 28° Broach

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523158331 Catalog Number : 2168-442-219

Device Description : Tesera-k ALIF, 42W X 32D, 19mm, 28° Broach

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523158348 Catalog Number : 2168-442-221

Device Description : Tesera-k ALIF, 42W X 32D, 21mm, 28° Broach

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523158355 Catalog Number : 3167-006-000

Device Description : 27x24 Tesera-k A ALIF Instrument Case

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523158393 Catalog Number : 2167-012-015

Device Description : Angled Retaining Hex Driver

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523160471 Catalog Number : 2167-011-003

Device Description : Angled Tesera-k ALIF Cage Inserter

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523160488 Catalog Number : 2167-013-001

Device Description : Angled Cover Plate Inserter

Device Class : 1

Duns Number: 116995646

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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