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) (4) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (4) Appliance, Fixation, Spinal Interlaminal (KWP) (3) Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (3) Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (3)

Premarket Exempt

No Yes

Clear

Biolign - 06009696222561 Catalog Number : TL361607-10

Device Description : Biolign Tlif Cage 36mm (7mm x 10deg)

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Biolign - 06009696222578 Catalog Number : TL361608-10

Device Description : Biolign Tlif Cage 36mm (8mm x 10deg)

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Biolign - 06009696222899 Catalog Number : BCC180406

Device Description : Cervical Cage 18 x 4 x 6mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Biolign - 06009696222905 Catalog Number : BCC180507

Device Description : Biolign Cervical Cage 18 x 5 x 7mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Biolign - 06009696222912 Catalog Number : BCC180608

Device Description : Cervical Cage 18 x 6 x 8mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Biolign - 06009696222929 Catalog Number : TL361606-10

Device Description : Biolign Tlif Cage 36mm (6mm x 10deg)

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Vertefix II - 06009696223056 Catalog Number : CZE8535MX

Device Description : Vertefix II Multi-Axial Extension Screw 8.5 x 35mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Vertefix II - 06009696223162 Catalog Number : MI5050TX

Device Description : Alignment Rod 5.5 x 50mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

Vertefix II - 06009696223179 Catalog Number : MI5075TX

Device Description : Alignment Rod 5.5 x75mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

Vertefix II - 06009696223186 Catalog Number : MI5100TX

Device Description : Alignment Rod 5.5 x 100mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : Yes

Product Code : KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

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