SPICCA Cervical Fusion Cages
by Southern Medical (Pty), Ltd.
510(k) K230607
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK230607 | Date14 Aug 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ODP
- FDA applicant
- Southern Medical (Pty) , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
SPICCA Cervical Fusion Cages are intervertebral fusion devices with integrated fixation designed for cervical spinal applications. They are intended to facilitate spinal fusion by providing structural support and promoting bone growth between adjacent vertebrae.
These devices are supplied sterile and are intended for single-use implantation in orthopedic surgical settings. They have received FDA 510(k) clearance (K230607) as substantially equivalent to a predicate device, with product code ODP and classification under orthopedic medical specialty.
Other devices from Southern Medical (Pty), Ltd.
Questions
AI-generated answers, 27 Sep 2026
What is the SPICCA Cervical Fusion Cage used for?
The SPICCA Cervical Fusion Cage is an intervertebral fusion device with integrated fixation designed for cervical spinal applications. It is intended to facilitate spinal fusion by providing structural support and promoting bone growth between adjacent vertebrae during orthopedic surgical procedures.
How is the SPICCA Cervical Fusion Cage supplied and is it reusable?
The SPICCA Cervical Fusion Cage is supplied sterile and is intended for single-use implantation only. It is not designed for reuse, and re-sterilization or re-implantation could compromise device integrity and patient safety.
What regulatory pathway was used for the SPICCA Cervical Fusion Cage?
The SPICCA Cervical Fusion Cage received FDA 510(k) clearance under submission number K230607, demonstrating substantial equivalence to a predicate device. It is classified under product code ODP within the orthopedic medical specialty.