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Elite Surgical Supplies (pty) Ltd: FDA-registered device maker in Pretoria Gauteng, South Africa, 4 510(k) clearances

Name: Elite Surgical Supplies (pty) Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Elite Surgical Supplies (pty) Ltd is registered with the FDA (registration 3005325790) in Pretoria Gauteng, South Africa. It lists 13 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 30, 2020. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3005325790
Address: 54 De Havilland Crescent, Persequor Technopark Persequor, Pretoria Gauteng, South Africa, 0020
Owner or operator: Elite Surgical Supplies (Pty) Ltd (10025504)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: April 18, 2008
Registered through: 2026
Brand names listed: Biolign ACIF, Biolign Rotoloc, Biolign STACC, Biolign TLIF, VMS ANGLED RULER, VMS FEMORAL GAUGE, VMS Left Anterior Aiming Device, VMS Left Posterior Aiming Device and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Interlaminal	KWP	2	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Manufacturer	accessdata.fda.gov
Caliper	KTZ	1	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2	Manufacturer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Template	HWT	1	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Complaint file establishment, Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 30, 2020	K200523	Biolign® Roto-Loc Cervical Plate System	KWQ	Substantially Equivalent	Elite Surgical Supplies (Pty), Ltd.	accessdata.fda.gov
October 29, 2013	K130274	BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM	MAX	Substantially Equivalent	Elite Surgical Supplies (Pty), Ltd.	accessdata.fda.gov
January 28, 2008	K080075	MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM	MNI	Substantially Equivalent	Elite Surgical Supplies (Pty), Ltd.	accessdata.fda.gov
August 30, 2007	K063453	VERTEFIX PEDICLE SCREW SPINAL SYSTEM	MNI	Substantially Equivalent	Elite Surgical Supplies (Pty), Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 30, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.