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) (6) System, Facet Screw Spinal Device (MRW) (4)

Premarket Exempt

Yes No

Clear

primaLOK FF - 00813210022003 Catalog Number :

Device Description : Removal Driver

Device Class : U

Duns Number: 832543255

Premarket Exempt : No

Product Code : MRW

Prescription Use : Yes

Device Count : 1

primaLOK FF - 00813210022010 Catalog Number :

Device Description : Implant Driver

Device Class : U

Duns Number: 832543255

Premarket Exempt : No

Product Code : MRW

Prescription Use : Yes

Device Count : 1

primaLOK FF - 00813210022027 Catalog Number :

Device Description : Threaded Implant Holder Shaft - Cannulated

Device Class : U

Duns Number: 832543255

Premarket Exempt : No

Product Code : MRW

Prescription Use : Yes

Device Count : 1

primaLOK FF - 00813210022034 Catalog Number :

Device Description : Threaded Implant Holder Shaft - Solid

Device Class : U

Duns Number: 832543255

Premarket Exempt : No

Product Code : MRW

Prescription Use : Yes

Device Count : 1

primaLOK FF - 00813210022041 Catalog Number :

Device Description : Guide Wire (single use, disposable)

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

primaLOK-FF - 00813210022058 Catalog Number :

Device Description : 3mm Cannulated Drill

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

primaLOK FF - 00813210022065 Catalog Number :

Device Description : Cannulated Tap

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

primaLOK FF - 00813210022072 Catalog Number :

Device Description : Guide Wire Stiffener

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

primaLOK FF - 00813210022089 Catalog Number :

Device Description : Standard Cannula

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

primaLOK FF - 00813210022096 Catalog Number :

Device Description : EMG Cannula

Device Class : 1

Duns Number: 832543255

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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