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FDA 510(k)

SPICCA Stand-Alone Cervical Fusion Cages

K-Number: K230608 · 2023-08-14

ApplicantSouthern Medical (Pty) , Ltd.
Decision Date2023-08-14
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPICCA Stand-Alone Cervical Fusion Cages 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 2023-08-14 under 510(k) number K230608. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPICCA Stand-Alone Cervical Fusion Cages?

SPICCA Stand-Alone Cervical Fusion Cages is a medical device that received FDA 510(k) clearance on 2023-08-14. The listed applicant is Southern Medical (Pty) , Ltd.. The 510(k) number is K230608.

When did SPICCA Stand-Alone Cervical Fusion Cages receive FDA 510(k) clearance?

SPICCA Stand-Alone Cervical Fusion Cages received FDA 510(k) clearance on 2023-08-14, under 510(k) number K230608.

Who is the listed applicant for SPICCA Stand-Alone Cervical Fusion Cages?

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 SPICCA Stand-Alone Cervical Fusion Cages?

The FDA product code for SPICCA Stand-Alone Cervical Fusion Cages is OVE.

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_INVITATIONNCT06938607Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain PlacementNOT_YET_RECRUITINGNCT07721493Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative DiseaseNOT_YET_RECRUITING

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) SystemK230607SPICCA Cervical Fusion CagesK231145Axis Anterior Cervical Plate SystemK221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)K221447Southern Anterior Screw Fixated Cage (SASCA)

Related Devices (Code: OVE)

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.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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