KISCO INTERNATIONAL

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Filters

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

Orthosis, Spinal Pedicle Fixation (MNI) (8) Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (2)

Premarket Exempt

Clear

Odalys - 03700406301745 Catalog Number : ODSS55655

Device Description : The Odalys is a pedicle screw spinal system.

Device Class : 2

Duns Number: 393107719

Premarket Exempt : No

Product Code : MNI

Prescription Use : Yes

Device Count : 1

Odalys - 03700406301769 Catalog Number : ODSS55755

Device Description : The Odalys is a pedicle screw spinal system.

Device Class : 2

Duns Number: 393107719

Premarket Exempt : No

Product Code : MNI

Prescription Use : Yes

Device Count : 1

Odalys - 03700406302612 Catalog Number : ODPS55755

Device Description : The Odalys is a pedicle screw spinal system.

Device Class : 2

Duns Number: 393107719

Premarket Exempt : No

Product Code : MNI

Prescription Use : Yes

Device Count : 1

Odalys - 03700406302629 Catalog Number : ODPS55555

Device Description : The Odalys is a pedicle screw spinal system.

Device Class : 2

Duns Number: 393107719

Premarket Exempt : No

Product Code : MNI

Prescription Use : Yes

Device Count : 1

Odalys - 03700406302636 Catalog Number : ODPS55655

Device Description : The Odalys is a pedicle screw spinal system.

Device Class : 2

Duns Number: 393107719

Premarket Exempt : No

Product Code : MNI

Prescription Use : Yes

Device Count : 1

Odalys - 03700406302643 Catalog Number : ODPS55545

Device Description : The Odalys is a pedicle screw spinal system.

Device Class : 2

Duns Number: 393107719

Premarket Exempt : No

Product Code : MNI

Prescription Use : Yes

Device Count : 1

Odalys - 03700406302650 Catalog Number : ODPS55550

Device Description : The Odalys is a pedicle screw spinal system.

Device Class : 2

Duns Number: 393107719

Premarket Exempt : No

Product Code : MNI

Prescription Use : Yes

Device Count : 1

Odalys - 03700406320678 Catalog Number : ODSS55555

Device Description : The Odalys is a pedicle screw spinal system.

Device Class : 2

Duns Number: 393107719

Premarket Exempt : No

Product Code : MNI

Prescription Use : Yes

Device Count : 1

L-Varlock - 03700406328001 Catalog Number : VAL-CA-10-08

Device Description : The L-Varlock is a lumbar cage, for intervertebral body fusion.

Device Class : 2

Duns Number: 393107719

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

L-Varlock - 03700406328018 Catalog Number : VAL-CA-10-09

Device Description : The L-Varlock is a lumbar cage, for intervertebral body fusion.

Device Class : 2

Duns Number: 393107719

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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