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

Orthopedic Manual Surgical Instrument (LXH) (5) Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (4) Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (1)

Premarket Exempt

No Yes

Clear

VariLift-L - 00813210020610 Catalog Number :

Device Description : 13mm Threaded Trial

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

VariLift-L - 00813210020627 Catalog Number :

Device Description : 14mm Threaded Trial

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

VariLift-L - 00813210020634 Catalog Number :

Device Description : 15mm Threaded Trial

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

VariLift-LX - 00813210020641 Catalog Number :

Device Description : End Cap Driver

Device Class : 2

Duns Number: 832543255

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

VariLift-LX - 00813210020658 Catalog Number :

Device Description : Extended End Cap Driver

Device Class : 2

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : MAX

Prescription Use : Yes

Device Count : 1

VariLift-LX - 00813210020665 Catalog Number :

Device Description : MI Graft Funnel

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

VariLift-LX - 00813210020672 Catalog Number :

Device Description : MI Graft Impactor

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

VariLift-LX - 00813210020689 Catalog Number :

Device Description : Expander, 24mm

Device Class : 2

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : MAX

Prescription Use : Yes

Device Count : 1

VariLift-LX - 00813210020696 Catalog Number :

Device Description : Expander, 28mm

Device Class : 2

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : MAX

Prescription Use : Yes

Device Count : 1

VariLift-C - 00813210020702 Catalog Number :

Device Description : Insertion Wrench, T-Handle

Device Class : 2

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : ODP

Prescription Use : Yes

Device Count : 1

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