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. - 00841523100019 Catalog Number : 1028-003-001

Device Description : Locking Cover Plate

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100026 Catalog Number : 1028-453-020

Device Description : 4.5mm X 20mm Variable Angle Screw

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100033 Catalog Number : 1028-453-025

Device Description : 4.5mm X 25mm Variable Angle Screw

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100040 Catalog Number : 1028-453-030

Device Description : 4.5mm X 30mm Variable Angle Screw

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100057 Catalog Number : 1028-453-035

Device Description : 4.5mm X 35mm Variable Angle Screw

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100064 Catalog Number : 1029-503-020

Device Description : 5.0mm X 20mm Constrained Screw

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100071 Catalog Number : 1029-503-025

Device Description : 5.0mm X 25mm Constrained Screw

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100088 Catalog Number : 1029-503-030

Device Description : 5.0mm X 30mm Constrained Screw

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100095 Catalog Number : 1029-503-035

Device Description : 5.0mm X 35mm Constrained Screw

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100101 Catalog Number : 1031-302-611

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 11mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

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