TITAN SPINE, LLC

Address:6140 W. EXECUTIVE DR,MEQUON,WI,53092,US

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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

Intervertebral fusion device with integrated fixation, lumbar (OVD) (9) Intervertebral fusion device with bone graft, lumbar (MAX) (1)

Premarket Exempt

No Yes

Clear

ENDOSKELETON® TAS - 00191375001546 Catalog Number : 2312-1114

Device Description : Interbody Fusion Device 12 Degree Hybrid 14mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TAS - 00191375001560 Catalog Number : 2312-1116

Device Description : Interbody Fusion Device 12 Degree Hybrid 16mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TAS - 00191375001577 Catalog Number : 2312-1117

Device Description : Interbody Fusion Device 12 Degree Hybrid 17mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TAS - 00191375002383 Catalog Number : 2300-1100

Device Description : Bone Screw Awl

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TAS - 00191375002390 Catalog Number : 2300-1101

Device Description : Bone Screw Curved Awl

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TAS - 00191375002406 Catalog Number : 2312-7410

Device Description : 12 Deg Lordotic, Rasp, Hybrid, 10mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TAS - 00191375002413 Catalog Number : 2312-7412

Device Description : 12 Deg Lordotic, Rasp, Hybrid, 12mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TAS - 00191375002420 Catalog Number : 2312-7414

Device Description : 12 Deg Lordotic, Rasp, Hybrid, 14mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TAS - 00191375002437 Catalog Number : 2312-7416

Device Description : 12 Deg Lordotic, Rasp, Hybrid, 16mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA - 00191375002444 Catalog Number : 2312-9408

Device Description : Distractor, Hybrid, 36 x 21 x 8mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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