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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 a medical device manufactured by Southern Medical (Pty) , Ltd.. It received FDA 510(k) clearance on 2023-08-14 under approval 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. It is manufactured by Southern Medical (Pty) , Ltd.. The 510(k) number is K230608.

When was SPICCA Stand-Alone Cervical Fusion Cages approved by the FDA?

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

What company makes SPICCA Stand-Alone Cervical Fusion Cages?

SPICCA Stand-Alone Cervical Fusion Cages is manufactured by Southern Medical (Pty) , Ltd..

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

NCT07596953 Efficacy of TECAR Therapy on Patient With Mechanical Neck Pain NOT_YET_RECRUITING NCT07586644 Combined rTMS and tSCS for Upper Limb Recovery in Cervical SCI NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT06893653 Focal Muscle Vibration and tDCS on Motor Recovery in Stroke COMPLETED NCT06862440 Kegg Fertility Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 38273730 Ten-Year Risk of Recall of Novel Spine Devices. Spine (2024) PMID: 28256243 Mechanical performance of cervical intervertebral body fusion devices: A systematic analysis of data submitted to the Food and Drug Administration. Journal of biomechanics (2017)

Other Devices by Southern Medical (Pty) , Ltd.

K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF) K221447Southern Anterior Screw Fixated Cage (SASCA) K230607SPICCA Cervical Fusion Cages K231145Axis Anterior Cervical Plate System K253373Southern Craniomaxillofacial (CMF) System

Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, 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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