WENZEL SPINE, INC.

Address:1130 Rutherford Ln #200, Austin, TX 78753,Austin,TX,78753,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) (5) Orthopedic Manual Surgical Instrument (LXH) (5)

Premarket Exempt

No Yes

Clear

VariLift-L - 00813210020450 Catalog Number :

Device Description : 13/15mm Retainer

Device Class : 2

Duns Number: 832543255

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

VariLift-L - 00813210020467 Catalog Number :

Device Description : Expander

Device Class : 2

Duns Number: 832543255

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

VariLift-L - 00813210020474 Catalog Number :

Device Description : Reducer, Molded Handle

Device Class : 2

Duns Number: 832543255

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

VariLift-L - 00813210020542 Catalog Number :

Device Description : Inserter Alignment Guide

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

VariLift-L - 00813210020559 Catalog Number :

Device Description : 9/11mm Retainer

Device Class : 2

Duns Number: 832543255

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

VariLift-L - 00813210020566 Catalog Number :

Device Description : Inserter, 10mm-12mm, Molded Handle

Device Class : 2

Duns Number: 832543255

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

VariLift-L - 00813210020573 Catalog Number :

Device Description : Retainer Alignment Guide

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

VariLift-L - 00813210020580 Catalog Number :

Device Description : 10mm Threaded Trial

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

VariLift-L - 00813210020597 Catalog Number :

Device Description : 11mm Threaded Trial

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

VariLift-L - 00813210020603 Catalog Number :

Device Description : 12mm Threaded Trial

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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