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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 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 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. The listed applicant is Southern Medical (Pty) , Ltd.. The 510(k) number is K230607.

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

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

Who is the listed applicant for SPICCA 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 Cervical Fusion Cages?

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

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

Related Devices (Code: ODP)

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.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.

Official Source

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

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