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) (9) Orthosis, Spinal Pedicle Fixation (MNI) (9) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (9) Appliance, Fixation, Spinal Intervertebral Body (KWQ) (1)

Premarket Exempt

No Yes

Clear

Biolign Rotoloc - 06009708425713 Catalog Number : RLSS4618

Device Description : Roto-Loc Variable Angled Cervical Screw 4.6 x 18mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426024 Catalog Number : CZ5530CT

Device Description : MULTI AXIAL PEDICLE SCREW 5.5 X 30

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426031 Catalog Number : CZ5535CT

Device Description : MULTI AXIAL PEDICLE SCREW 5.5 X 35

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426048 Catalog Number : CZ5540CT

Device Description : MULTI AXIAL PEDICLE SCREW 5.5 X 40

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426055 Catalog Number : CZ5545CT

Device Description : VERTEFIX MULTI AXIAL SCREW 5.5 X 45

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426062 Catalog Number : CZ5550CT

Device Description : MULTI AXIAL PEDICLE SCREW 5.5 X 50

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426079 Catalog Number : CZ6530CT

Device Description : MULTI AXIAL PEDICLE SCREW 6.5 X 30

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426086 Catalog Number : CZ6535CT

Device Description : MULTI AXIAL PEDICLE SCREW 6.5 X 35

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426093 Catalog Number : CZ6540CT

Device Description : MULTI AXIAL PEDICLE SCREW 6.5 X 40

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

VERTEFIX - 06009708426109 Catalog Number : CZ6545CT

Device Description : MULTI AXIAL PEDICLE SCREW 6.5 X 45

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

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