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

Appliance, Fixation, Spinal Interlaminal (KWP) (5) Orthopedic Manual Surgical Instrument (LXH) (5)

Premarket Exempt

Yes No

Clear

primaLOK FF - 00813210022102 Catalog Number :

Device Description : Access Needle (sterile, single use)

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

primaLOK FF - 00813210022119 Catalog Number :

Device Description : Single Bevel Access Needle (sterile, single use)

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

primaLOK FF - 00813210022126 Catalog Number :

Device Description : Cannula Inserter

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

primaLOK FF - 00813210022133 Catalog Number :

Device Description : Ratcheting Driver Handle

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

primaLOK FF - 00813210022157 Catalog Number :

Device Description : 3mm Cannulated Power Drill

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

primaLOK SP - 00813210022249 Catalog Number :

Device Description : Implant Inserter

Device Class : 2

Duns Number: 832543255

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

primaLOK SP - 00813210022256 Catalog Number :

Device Description : Lock Ring Compressor

Device Class : 2

Duns Number: 832543255

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

primaLOK SP - 00813210022263 Catalog Number :

Device Description : Removal Tool

Device Class : 2

Duns Number: 832543255

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

primaLOK SP - 00813210022270 Catalog Number :

Device Description : Inserter Compressor II

Device Class : 2

Duns Number: 832543255

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

primaLOK SP - 00813210022287 Catalog Number :

Device Description : Offset Provisional Locker

Device Class : 2

Duns Number: 832543255

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

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