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 - M682PI17490 Catalog Number : PI-1749

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

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON DPK - M682PI17500 Catalog Number : PI-1750

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

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON DPK - M682PI17640 Catalog Number : PI-1764

Device Description : Anterior Double Action Rongeur, 8mm

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON TL RETRACTOR - M682R14154011740 Catalog Number : R14154-01-174

Device Description : Retractor Body, Steel

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON TL RETRACTOR - M682R1415401ALU0 Catalog Number : R14154-01-ALU

Device Description : Retractor Body, Aluminum

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON TL RETRACTOR - M682R14154020900 Catalog Number : R14154-02-090

Device Description : Blade Set (Cephalad, Caudal, Posterior), 90mm

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON TL RETRACTOR - M682R14154021000 Catalog Number : R14154-02-100

Device Description : Blade Set (Cephalad, Caudal, Posterior), 100mm

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON TL RETRACTOR - M682R14154021100 Catalog Number : R14154-02-110

Device Description : Blade Set (Cephalad, Caudal, Posterior), 110mm

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON TL RETRACTOR - M682R14154021200 Catalog Number : R14154-02-120

Device Description : Blade Set (Cephalad, Caudal, Posterior), 120mm

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON TL RETRACTOR - M682R14154021300 Catalog Number : R14154-02-130

Device Description : Blade Set (Cephalad, Caudal, Posterior), 130mm

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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