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) (8) Appliance, Fixation, Spinal Interlaminal (KWP) (2)

Premarket Exempt

Yes No

Clear

primaLOK SP - 00813210022294 Catalog Number :

Device Description : Post Plate Inserter

Device Class : 2

Duns Number: 832543255

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

primaLOK SP - 00813210022300 Catalog Number :

Device Description : Polyaxial Plate Inserter

Device Class : 2

Duns Number: 832543255

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

primaLOK-SP - 00813210022317 Catalog Number :

Device Description : Retractor Frame (Locking Ring Compressor)

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

primaLOK-SP - 00813210022331 Catalog Number :

Device Description : Distractor Screw Driver Ha

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

primaLOK-SP - 00813210022348 Catalog Number :

Device Description : Implant Sizer Handle

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

primaLOK-SP - 00813210022355 Catalog Number :

Device Description : Retractor Extension

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

primaLOK-SP - 00813210022362 Catalog Number :

Device Description : Laminar Spread

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

primaLOK-SP - 00813210022379 Catalog Number :

Device Description : Backup Plate Caddy

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

primaLOK-SP - 00813210022386 Catalog Number :

Device Description : Implant Sizer - 4mm

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

primaLOK-SP - 00813210022393 Catalog Number :

Device Description : Implant Sizer - 6mm

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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