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 Intervertebral Body (KWQ) (10)

Premarket Exempt

No Yes

Clear

Biolign Rotoloc - 06009708425614 Catalog Number : RLSS4214

Device Description : Roto-Loc Variable Angled Cervical Screw 4.2 x 14mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Biolign Rotoloc - 06009708425621 Catalog Number : RLSS4216

Device Description : Roto-Loc Variable Angled Cervical Screw 4.2 x 16mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Biolign Rotoloc - 06009708425638 Catalog Number : RLSS4218

Device Description : Roto-Loc Variable Angled Cervical Screw 4.2 x 18mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Biolign Rotoloc - 06009708425645 Catalog Number : RLFS4612

Device Description : Roto-Loc Fixed Angled Cervical Screw 4.6 x 12mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Biolign Rotoloc - 06009708425652 Catalog Number : RLFS4614

Device Description : Roto-Loc Fixed Angled Cervical Screw 4.6 x 14mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Biolign Rotoloc - 06009708425669 Catalog Number : RLFS4616

Device Description : Roto-Loc Fixed Angled Cervical Screw 4.6 x 16mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Biolign Rotoloc - 06009708425676 Catalog Number : RLFS4618

Device Description : Roto-Loc Fixed 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

Biolign Rotoloc - 06009708425683 Catalog Number : RLSS4612

Device Description : Roto-Loc Variable Angled Cervical Screw 4.6 x 12mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Biolign Rotoloc - 06009708425690 Catalog Number : RLSS4614

Device Description : Roto-Loc Variable Angled Cervical Screw 4.6 x 14mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Biolign Rotoloc - 06009708425706 Catalog Number : RLSS4616

Device Description : Roto-Loc Variable Angled Cervical Screw 4.6 x 16mm

Device Class : 2

Duns Number: 568359710

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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