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Southern Medical (Pty), Ltd.

South Africa(FDA 510(k) applicant) Last updated 26 Oct 2026

Devices
109
Registries
GUDIDFDA
FDA recalls
0

Catalogue109

Page 1 of 3

Showing 1-50 of 109

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Southern Medical (Pty) Ltd IRENE Gauteng · ZA FEI 3003898943

What Southern Medical (Pty), Ltd. makes

Southern Medical (Pty), Ltd. manufactures orthopedic and neurosurgical implants, including anterior cervical plate systems, screw-fixated cages, and stand-alone cervical fusion cages. The company also produces transforaminal lumbar interbody fusion devices and craniomaxillofacial systems.

These devices are classified as Class II medical products and are listed in the FDA 510(k) registry. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

How many devices does Southern Medical (Pty), Ltd. have in the registry?

The registry currently lists 109 devices for Southern Medical (Pty), Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Southern Medical (Pty), Ltd.'s devices?

Among its 50 most recently registered devices, Southern Medical (Pty), Ltd. has devices listed in FDA GUDID (50 devices).

What risk classes do Southern Medical (Pty), Ltd.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Southern Medical (Pty), Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Southern Medical (Pty), Ltd. in the registry?

The most recently registered devices listed for Southern Medical (Pty), Ltd. include TLIF-C-35-08, TLIF-C-30-07, TLIF-C-35-10 and TLIF-C-30-09.

Which FDA establishments are linked to Southern Medical (Pty), Ltd.?

1 FDA establishment is linked to Southern Medical (Pty), Ltd. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.

Information

DUNS number
567466073