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) (4) Intervertebral fusion device with bone graft, lumbar (MAX) (3) SPINAL VERTEBRAL BODY REPLACEMENT DEVICE (MQP) (3)

Premarket Exempt

No Yes

Clear

ENDOSKELETON® TA VBR - 00191375000044 Catalog Number : 2107-0318

Device Description : Interbody Fusion Device 7 Degree X-Large 18mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA VBR - 00191375000051 Catalog Number : 2107-0320

Device Description : Interbody Fusion Device 7 Degree X-Large 20mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA VBR - 00191375000143 Catalog Number : 2200-0001

Device Description : Implant Caddy

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA - 00191375001232 Catalog Number : 2106-1010

Device Description : Instrument Case

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA - 00191375001249 Catalog Number : 2106-1014

Device Description : Implant Tray with Caddies

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA - 00191375001256 Catalog Number : 2106-1009

Device Description : Implant Case

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TAS - 00191375001508 Catalog Number : 2312-1110

Device Description : Interbody Fusion Device 12 Degree Hybrid 10mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TAS - 00191375001515 Catalog Number : 2312-1111

Device Description : Interbody Fusion Device 12 Degree Hybrid 11mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TAS - 00191375001522 Catalog Number : 2312-1112

Device Description : Interbody Fusion Device 12 Degree Hybrid 12mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TAS - 00191375001539 Catalog Number : 2312-1113

Device Description : Interbody Fusion Device 12 Degree Hybrid 13mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

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