Cellent Spinal Systems
by Jiangsu Trauhui Medical Instrument Co., Ltd.
510(k) K172826
Active
Valid until
No date given
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK172826 | Date10 Oct 2018 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- NKB
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Cellent Spinal Systems is classified under product code NKB as an orthopedic device designed for spinal applications. It is intended for use in spinal surgical procedures, providing structural support and stabilization to the spine.
This device is supplied by Jiangsu Trauhui Medical Instrument Co., Ltd., with FDA 510(k) clearance (K172826) and MDD authorization. It is intended for single-use or reusable applications in surgical settings, adhering to regulatory standards for orthopedic implants. The device’s specifications were reviewed under the Orthopedic (OR) Advisory Committee and deemed substantially equivalent to predicate devices.
Other devices from Jiangsu Trauhui Medical Instrument Co., Ltd.
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Questions
AI-generated answers, 18 Sep 2026
What types of spinal surgical procedures is the Cellent Spinal Systems designed to support?
The Cellent Spinal Systems is designed to provide structural support and stabilization during spinal surgical procedures, specifically categorized under product code NKB for orthopedic spinal applications. It is intended for use in surgeries where maintaining spinal alignment or reinforcing the spine is critical, such as fusions or stabilization procedures.
Is the Cellent Spinal Systems intended for single-use or reusable applications, and how should it be handled?
The Cellent Spinal Systems is supplied for both single-use and reusable applications in surgical settings. The manufacturer, Jiangsu Trauhui Medical Instrument Co., Ltd., specifies compliance with regulatory standards for orthopedic implants, so proper sterilization and reprocessing protocols must be followed if reused, as dictated by facility policies and regulatory guidelines.
How was the regulatory pathway for the Cellent Spinal Systems determined, and what does this mean for its use?
The Cellent Spinal Systems received FDA 510(k) clearance (K172826) under the Traditional pathway, with a decision of Substantially Equivalent (SESE) to predicate devices. This means the FDA determined it met the same performance standards as existing spinal stabilization devices, allowing it to be marketed legally in the U.S. for its intended spinal surgical applications. The device was also authorized under the MDD (Medical Device Directive) in its home market.
Who is the manufacturer, and where can I find contact information for inquiries?
The manufacturer of the Cellent Spinal Systems is Jiangsu Trauhui Medical Instrument Co., Ltd., located at #2 Longqing Rd., Wujin Hi-Tech Industrial Zone, Changzhou, China (postal code 213118). For inquiries, you may contact Zhou Yu, though verification of contact details should be confirmed directly with the manufacturer or distributor, as listed on their official documentation.