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

Appliance, Fixation, Spinal Interlaminal (KWP) (10) Orthosis, Spinal Pedicle Fixation (MNI) (10) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (10)

Premarket Exempt

Yes No

Clear

VERTEFIX - 06009708426116 Catalog Number : CZ6550CT

Device Description : MULTI AXIAL PEDICLE SCREW 6.5 X 50

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426123 Catalog Number : CZ6555CT

Device Description : MULTI AXIAL PEDICLE SCREW 6.5 X 55

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426130 Catalog Number : CZ7530CT

Device Description : MULTI AXIAL PEDICLE SCREW 7.5 X 30

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426147 Catalog Number : CZ7535CT

Device Description : MULTI AXIAL PEDICLE SCREW 7.5 X 35

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426154 Catalog Number : CZ7540CT

Device Description : MULTI AXIAL PEDICLE SCREW 7.5 X 40

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426161 Catalog Number : CZ7545CT

Device Description : MULTI AXIAL PEDICLE SCREW 7.5 X 45

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426178 Catalog Number : CZ7550CT

Device Description : MULTI AXIAL PEDICLE SCREW 7.5 X 50

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426185 Catalog Number : CZ7555CT

Device Description : MULTI AXIAL PEDICLE SCREW 7.5 X 55

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426192 Catalog Number : CZ8535CT

Device Description : MULTI AXIAL PEDICLE SCREW 8.5 X 35

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426208 Catalog Number : CZ8540CT

Device Description : MULTI AXIAL PEDICLE SCREW 8.5 X 40

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

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