Southern Medical: Orthopedic and Neurosurgical Implants

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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

What types of medical devices does Southern Medical (Pty), Ltd. manufacture?

Southern Medical (Pty), Ltd. manufactures a range of orthopedic and neurosurgical implants. Their product portfolio includes the Axis Anterior Cervical Plate System, various cervical fusion cages such as the SPICCA and SASCA models, transforaminal lumbar interbody fusion devices, and craniomaxillofacial systems. These products are designed to support surgical procedures within the orthopedic and neurosurgical fields.

Where is Southern Medical (Pty), Ltd. based?

Southern Medical (Pty), Ltd. is based in the United States. This location serves as the primary base for the company's operations in the manufacturing of their orthopedic and neurosurgical implant systems.

How are the devices from Southern Medical (Pty), Ltd. classified and registered?

The devices produced by Southern Medical (Pty), Ltd. are classified as Class II medical products. Regarding their regulatory status, these specific devices are listed in the FDA 510(k) registry. This classification and registry listing indicate the regulatory pathway these devices have followed for market access in the United States.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: ZA
DUNS number: 567466073

Catalogue109

Tlif-C-35-08 Ref TLIF-C-35-08

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Tlif-C-35-07 Ref TLIF-C-35-07

Tlif-C-35-12 Ref TLIF-C-35-12

Tlif-C-35-13 Ref TLIF-C-35-13

Sasca-3-37-09 Ref SASCA-3-37-09

Axis CS40-12-SD Ref CS40-12-SD

Axis CS40-16-SD Ref CS40-16-SD

Axis CS40-14-SD Ref CS40-14-SD

Cmf Cns-Sd-1.5X5 Ref CNS-SD-1.5X5

Cmf Cns-Sd-1.5X4 Ref CNS-SD-1.5X4

Cmf Cns-Sd-2.0X5 Ref CNS-SD-2.0X5

Axis CS40-18-SD Ref CS40-18-SD

Cmf Cns-Sd-1.5X4-G Ref CNS-SD-1.5X4-G

Cmf Cns-Sd-2.0X6 Ref CNS-SD-2.0X6

Cmf Cns-Sd-1.5X6-G Ref CNS-SD-1.5X6-G

Cmf Cns-Sd-1.5X5-G Ref CNS-SD-1.5X5-G

Axis CS45-12-T Ref CS45-12-T

Axis CS45-14-T Ref CS45-14-T

Axis CS45-16-T Ref CS45-16-T

Axis CS45-18-T Ref CS45-18-T

Axis CP3-1L-19.5 Ref CP3-1L-19.5

Axis CP3-1L-21 Ref CP3-1L-21

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Axis CP3-1L-24 Ref CP3-1L-24

Axis CP3-1L-25.5 Ref CP3-1L-25.5

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Axis CP3-2L-32.5 Ref CP3-2L-32.5

Axis CP3-2L-37.5 Ref CP3-2L-37.5

Axis CP3-2L-42.5 Ref CP3-2L-42.5

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Axis CP3-2L-47.5 Ref CP3-2L-47.5

Axis CP3-3L-45 Ref CP3-3L-45

Axis CP3-3L-49 Ref CP3-3L-49

Axis CP3-3L-53 Ref CP3-3L-53

Axis CP3-3L-57 Ref CP3-3L-57

Axis CP3-3L-61 Ref CP3-3L-61

Axis CP3-3L-65 Ref CP3-3L-65

FDA establishments1

What Southern Medical (Pty) , Ltd. makes

Frequently asked questions

Information