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FDA 510(k)

Southern Anterior Screw Fixated Cage (SASCA)

K-Number: K221447 · 2022-10-14

ApplicantSouthern Medical (Pty) , Ltd.
Decision Date2022-10-14
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Southern Anterior Screw Fixated Cage (SASCA) is a medical device manufactured by Southern Medical (Pty) , Ltd.. It received FDA 510(k) clearance on 2022-10-14 under approval number K221447. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Southern Anterior Screw Fixated Cage (SASCA)?

Southern Anterior Screw Fixated Cage (SASCA) is a medical device that received FDA 510(k) clearance on 2022-10-14. It is manufactured by Southern Medical (Pty) , Ltd.. The 510(k) number is K221447.

When was Southern Anterior Screw Fixated Cage (SASCA) approved by the FDA?

Southern Anterior Screw Fixated Cage (SASCA) received FDA 510(k) clearance on 2022-10-14, under approval number K221447.

What company makes Southern Anterior Screw Fixated Cage (SASCA)?

Southern Anterior Screw Fixated Cage (SASCA) is manufactured by Southern Medical (Pty) , Ltd..

What is the FDA product code for Southern Anterior Screw Fixated Cage (SASCA)?

The FDA product code for Southern Anterior Screw Fixated Cage (SASCA) is OVD.

Related Clinical Trials

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07515092 Virtual Reality-Based Simulation Training for Antegrade Anterior Column Acetabular Screw Placement in Orthopedic Residents ENROLLING_BY_INVITATION

Other Devices by Southern Medical (Pty) , Ltd.

K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF) K230607SPICCA Cervical Fusion Cages K230608SPICCA Stand-Alone Cervical Fusion Cages K231145Axis Anterior Cervical Plate System K253373Southern Craniomaxillofacial (CMF) System

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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