Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005325790

FEI Number

3005325790

Entity Name

ELITE SURGICAL SUPPLIES (PTY) LTD

City/State/Country

Pretoria Gauteng, ZA

Establishment Address

54 De Havilland Crescent, Persequor Technopark, Persequor, Pretoria Gauteng 0020, ZA

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Elite Surgical Supplies (Pty) Ltd (Owner Number: 10025504)

Owner / Operator Contact Address

54 De Havilland Crescent,, Persequor Technopark, Pretoria, ZA-GT 0020, ZA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vertefix Spinal System VMS ANGLED RULER Biolign STACC Biolign TLIF Biolign ACIF Vertical Measurement System (VMS) Re-usable Tray VMS Template - Left Anterior Aiming Device VMS Template - Right Posterior Aiming Device VMS Template - Right Anterior Aiming Device VMS Template - Left Posterior Aiming Device Vertical Measurement System (VMS) Right Posterior Vertical Measurement System (VMS) Left Anterior Vertical Measurement System (VMS) Left Posterior Vertical Measurement System (VMS) Right Anterior

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2008-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2008-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2008-04-18
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2020-03-17
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2013-12-06
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2013-12-06
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-12-06
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-02-03
HWT	Template	Orthopedic	Class 1	888.4800	2022-04-28
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2020-03-17

Official Correspondent

Rudi Verbeek

US Agent Details

Jennifer Palinchik Business: JALEX Medical LLC Email: info@jalexmedical.com Phone: (440) 5410060

Related Public Records

Same Entity

Elite Surgical Supplies (Pty) Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K032604	Co-Ligne AG	GII SPINAL FIXATION SYSTEM	2004-01-20
K964304	Osteonics Corp.	OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY	1997-01-17
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14
K012175	Encore Orthopedics, Inc.	PASS SPINAL SYSTEM	2001-07-31
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011	Zimmer Inc.	2	SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

Similar Registrations

Registration Number	Establishment Name	Location
3009941480	LISI MEDICAL REmmele	Big Lake, MN, US
3004635447	C&W SWISS, INC.	CLAYTON, OH, US
3015869493	Jabil Switzerland Manufacturing GmbH (Mezzovico)	Mezzovico Ticino, CH
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US
3009417901	SYNTHES GMBH	Zuchwil Solothurn, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005325790. Last updated year: 2026. Please use registration number 3005325790 when referencing this establishment in official correspondence.