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

Intervertebral Fusion Device With Integrated Fixation, Lumbar (OVD) (10)

Premarket Exempt

No Yes

Clear

Kyocera Medical Technologies, Inc. - 00841523100316 Catalog Number : 1031-342-821

Device Description : Ti-6Al-4V ALIF Implant 34 x 28, 21mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100323 Catalog Number : 1031-383-011

Device Description : Ti-6Al-4V ALIF Implant 38 x 30, 11mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100330 Catalog Number : 1031-383-012

Device Description : Ti-6Al-4V ALIF Implant 38 x 30, 12mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100347 Catalog Number : 1031-383-013

Device Description : Ti-6Al-4V ALIF Implant 38 x 30, 13mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100354 Catalog Number : 1031-383-014

Device Description : Ti-6Al-4V ALIF Implant 38 x 30, 14mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100361 Catalog Number : 1031-383-015

Device Description : Ti-6Al-4V ALIF Implant 38 x 30, 15mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100378 Catalog Number : 1031-383-016

Device Description : Ti-6Al-4V ALIF Implant 38 x 30, 16mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100385 Catalog Number : 1031-383-017

Device Description : Ti-6Al-4V ALIF Implant 38 x 30, 17mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100392 Catalog Number : 1031-383-018

Device Description : Ti-6Al-4V ALIF Implant 38 x 30, 18mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100408 Catalog Number : 1031-383-019

Device Description : Ti-6Al-4V ALIF Implant 38 x 30, 19mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

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