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. - 00841523100217 Catalog Number : 1031-342-811

Device Description : Ti-6Al-4V ALIF Implant 34 x 28, 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. - 00841523100224 Catalog Number : 1031-342-812

Device Description : Ti-6Al-4V ALIF Implant 34 x 28, 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. - 00841523100231 Catalog Number : 1031-342-813

Device Description : Ti-6Al-4V ALIF Implant 34 x 28, 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. - 00841523100248 Catalog Number : 1031-342-814

Device Description : Ti-6Al-4V ALIF Implant 34 x 28, 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. - 00841523100255 Catalog Number : 1031-342-815

Device Description : Ti-6Al-4V ALIF Implant 34 x 28, 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. - 00841523100262 Catalog Number : 1031-342-816

Device Description : Ti-6Al-4V ALIF Implant 34 x 28, 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. - 00841523100279 Catalog Number : 1031-342-817

Device Description : Ti-6Al-4V ALIF Implant 34 x 28, 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. - 00841523100286 Catalog Number : 1031-342-818

Device Description : Ti-6Al-4V ALIF Implant 34 x 28, 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. - 00841523100293 Catalog Number : 1031-342-819

Device Description : Ti-6Al-4V ALIF Implant 34 x 28, 19mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100309 Catalog Number : 1031-342-820

Device Description : Ti-6Al-4V ALIF Implant 34 x 28, 20mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

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