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) (9) LIGHT, SURGICAL, FIBEROPTIC (FST) (1)

Premarket Exempt

No Yes

Clear

ENDOSKELETON TL RETRACTOR - M682R14154100 Catalog Number : R14154-10

Device Description : Wrench

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON TL RETRACTOR - M682R14154110 Catalog Number : R14154-11

Device Description : K-wire

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON TL RETRACTOR - M682R14154120 Catalog Number : R14154-12

Device Description : Dilator Holder

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON TL RETRACTOR - M682R14154170 Catalog Number : R14154-17

Device Description : Tray

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON TL RETRACTOR - M682R14154180 Catalog Number : R14154-18

Device Description : Blade Extension, Long

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON TL RETRACTOR - M682R141542150 Catalog Number : R14154-15

Device Description : Reusable Light Connector

Device Class : 2

Duns Number: 623316978

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

ENDOSKELETON TL RETRACTOR - M682R14154260 Catalog Number : R14154-26

Device Description : 4th Blade, 12x210mm, Titanium

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON TL RETRACTOR - M682R14154280 Catalog Number : R14154-28

Device Description : 4th Blade, 12x160mm, Titanium

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON TL RETRACTOR - M682R14154300 Catalog Number : R14154-30

Device Description : Table Arm without Base

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON TL RETRACTOR - M682R14154310 Catalog Number : R14154-31

Device Description : PEEK Dilator #1

Device Class : 1

Duns Number: 623316978

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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