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. - 00841523100415 Catalog Number : 1031-383-020

Device Description : Ti-6Al-4V ALIF Implant 38 x 30, 20mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100422 Catalog Number : 1031-383-021

Device Description : Ti-6Al-4V ALIF Implant 38 x 30, 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. - 00841523100439 Catalog Number : 1033-302-611

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 11mm 12° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100446 Catalog Number : 1033-302-612

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 12mm 12° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100453 Catalog Number : 1033-302-613

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 13mm 12° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100460 Catalog Number : 1033-302-614

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 14mm 12° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100477 Catalog Number : 1033-302-615

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 15mm 12° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100484 Catalog Number : 1033-302-616

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 16mm 12° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100491 Catalog Number : 1033-302-617

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 17mm 12° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100507 Catalog Number : 1033-302-618

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 18mm 12° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

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