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 bone graft, lumbar (MAX) (7) Intervertebral fusion device with integrated fixation, lumbar (OVD) (3)

Premarket Exempt

No Yes

Clear

ENDOSKELETON® TA - 00191375002451 Catalog Number : 2312-9409

Device Description : Distractor, Hybrid, 36 x 21 x 9mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA - 00191375002468 Catalog Number : 2312-9411

Device Description : Distractor, Hybrid, 36 x 21 x 11mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA - 00191375002475 Catalog Number : 2312-9413

Device Description : Distractor, Hybrid, 36 x 21 x 13mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA - 00191375002482 Catalog Number : 2312-9415

Device Description : Distractor, Hybrid, 36 x 21 x 15mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA - 00191375002499 Catalog Number : 2312-9417

Device Description : Distractor, Hybrid, 36 x 21 x 17mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TAS - 00191375002505 Catalog Number : 2900-1001

Device Description : Full Tray System

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TAS - 00191375002512 Catalog Number : 2900-1006

Device Description : Instrument Tray System

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TAS - 00191375002529 Catalog Number : 2900-1016

Device Description : Implant Tray System

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TT - 00191375002536 Catalog Number : 4110-2507

Device Description : Interbody Fusion Device Parallel Standard 7mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TT - 00191375002543 Catalog Number : 4110-2508

Device Description : Interbody Fusion Device Parallel Standard 8mm

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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