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

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (10)

Premarket Exempt

No Yes

Clear

ENDOSKELETON DPK - M682PI17350 Catalog Number : PI-1735

Device Description : Long Cobb Elevator, 15in Length, 1in Flat

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON DPK - M682PI17360 Catalog Number : PI-1736

Device Description : Long Osteotome, 15in Length, 1/4in, Straight

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON DPK - M682PI17410 Catalog Number : PI-1741

Device Description : Nerve Root Retractor, 10mm, X-Large

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON DPK - M682PI17420 Catalog Number : PI-1742

Device Description : 10in Kerrison Rongeur, 2mm

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON DPK - M682PI17430 Catalog Number : PI-1743

Device Description : 10in Kerrison Rongeur, 4mm

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON DPK - M682PI17440 Catalog Number : PI-1744

Device Description : 10in Kerrison Rongeur, 6mm

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON DPK - M682PI17450 Catalog Number : PI-1745

Device Description : 8in Kerrison Rongeur, 4mm

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON DPK - M682PI17460 Catalog Number : PI-1746

Device Description : Ferris Smith Pituitary, 10in Length, 3mm, Up

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON DPK - M682PI17470 Catalog Number : PI-1747

Device Description : Ferris Smith Pituitary, 10in Length, 4mm, Straight

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON DPK - M682PI17480 Catalog Number : PI-1748

Device Description : Ferris Smith Pituitary, 10in Length, 5mm, Straight

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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