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FDA 510(k)

SPICCA Cervical Fusion Cages

K-Number: K230607 · 2023-08-14

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

Device Summary

SPICCA 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 K230607. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPICCA Cervical Fusion Cages?

SPICCA 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 K230607.

When was SPICCA Cervical Fusion Cages approved by the FDA?

SPICCA Cervical Fusion Cages received FDA 510(k) clearance on 2023-08-14, under approval number K230607.

What company makes SPICCA Cervical Fusion Cages?

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

What is the FDA product code for SPICCA Cervical Fusion Cages?

The FDA product code for SPICCA Cervical Fusion Cages is ODP.

Related Clinical Trials

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 NCT06971835 INDUCE: A Prospective 2-Year Spine Registry ENROLLING_BY_INVITATION NCT04214535 Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels ACTIVE_NOT_RECRUITING NCT06904898 CONDUIT vs. PEEK Cages 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) K230608SPICCA Stand-Alone Cervical Fusion Cages K231145Axis Anterior Cervical Plate System K253373Southern Craniomaxillofacial (CMF) System

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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