Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003898943

FEI Number

3003898943

Entity Name

SOUTHERN MEDICAL (PTY) LTD

City/State/Country

IRENE Gauteng, ZA

Establishment Address

55 Regency, Route 21 Corporate Park, Irene, Pretoria, IRENE Gauteng 0062, ZA

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Southern Medical (Pty) Ltd (Owner Number: 9052759)

Owner / Operator Contact Address

55 Regency, Route 21 Corporate Park, Irene, --, Pretoria, ZA-GT 0062, ZA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Axis Southern SASCA Riven Caspar Distractor SPICCA SPICCA-SP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-09-05
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-01-11
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-12-18
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-09-05
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2023-02-15
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2023-09-05
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2021-10-14

Official Correspondent

Dalene Styger

US Agent Details

David Luiz Business: Southern Implants North America Inc. Email: david@southernimplants.com Phone: (561) 4720990

Related Public Records

Same Entity

Southern Medical (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
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03
K062643	Life Spine	KINETIC ANTERIOR CERVICAL PLATE	2006-11-16
K192492	Astura Medical, LLC	EL CAPITAN Anterior Lumber Interbody System	2020-04-21
K212498	Nexus Spine, LLC	Stable-L Standalone Lumbar Interbody System	2022-03-18
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05	Zimmer Spine, Inc.	2	ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

Registration Number	Establishment Name	Location
3009941480	LISI MEDICAL REmmele	Big Lake, MN, US
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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 3003898943. Last updated year: 2026. Please use registration number 3003898943 when referencing this establishment in official correspondence.