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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 the device name listed in this FDA 510(k) record. The listed applicant is Southern Medical (Pty) , Ltd.. It received FDA 510(k) clearance on 2022-10-14 under 510(k) 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. The listed applicant is Southern Medical (Pty) , Ltd.. The 510(k) number is K221447.

When did Southern Anterior Screw Fixated Cage (SASCA) receive FDA 510(k) clearance?

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

Who is the listed applicant for Southern Anterior Screw Fixated Cage (SASCA)?

The FDA 510(k) record lists Southern Medical (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

Other records listing Southern Medical (Pty) , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253373Southern Craniomaxillofacial (CMF) SystemK230608SPICCA Stand-Alone Cervical Fusion CagesK230607SPICCA Cervical Fusion CagesK231145Axis Anterior Cervical Plate SystemK221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)

Related Devices (Code: OVD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, 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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