ELITE SURGICAL SUPPLIES (PTY) LTD

Address:54 De Havilland Crescent, Persequor Technopark,Pretoria Gauteng,ZA

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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

Orthosis, Spinal Pedicle Fixation (MNI) (10) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (10)

Premarket Exempt

No Yes

Clear

Vertefix - 06009696221076 Catalog Number : SP5535T

Device Description : Mono Axial Pedicle Screw 5.5x35mm.

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Vertefix - 06009696221083 Catalog Number : SP5540T

Device Description : Mono Axial Pedicle Screw 5.5x40mm Titanium

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Vertefix - 06009696221090 Catalog Number : SP5545T

Device Description : Mono Axial Pedicle Screw 5.5x45mm Tianium.

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Vertefix - 06009696221106 Catalog Number : SP5550T

Device Description : Mono Axial Pedicle Screw 5.5x50mm Titanium

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Vertefix - 06009696221120 Catalog Number : SP6535T

Device Description : Mono Axial Pedicle Screw 6.5x35mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Vertefix - 06009696221137 Catalog Number : SP6540T

Device Description : Mono Axial Pedicle Screw 6.5x40mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Vertefix - 06009696221144 Catalog Number : SP6545T

Device Description : Mono Axial Pedicle Screw 6.5x45mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Vertefix - 06009696221151 Catalog Number : SP6550T

Device Description : Mono Axial Pedicle Screw 6.5x50mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Vertefix - 06009696221175 Catalog Number : SP7535T

Device Description : Mono Axial Pedicle Screw 7.5x35mm Titanium

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Vertefix - 06009696221182 Catalog Number : SP7540T

Device Description : Mono Axial Pedicle Screw 7.5x40mm Titanium

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

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