Isobar Semi-Rigid Spinal System
510(k) K991326
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991326 | Date8 Nov 1999 | 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- Withdrawn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
- MNI
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Isobar Semi-Rigid Spinal System is a Class II orthopedic device designed for spinal stabilization. It consists of components intended to provide controlled flexibility and support to the spine, aiding in the treatment of spinal deformities or instability. The system is categorized under product code MNI, indicating its use in spinal fixation and alignment procedures.
This device is supplied as a reusable system and is intended for surgical use in controlled clinical environments. It has received FDA 510(k) clearance under the Traditional pathway, with a clearance date of November 8, 1999. The system is regulated under the FDA’s Class II orthopedic device classification, ensuring compliance with established safety and performance standards for spinal stabilization applications.
Other devices from Scien'Tx USA, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Isobar Semi-Rigid Spinal System used for?
The Isobar Semi-Rigid Spinal System is designed for spinal stabilization, providing controlled flexibility and support to the spine. It is intended to assist in the treatment of spinal deformities or instability by maintaining proper alignment during recovery or surgical intervention. This controlled flexibility helps reduce rigidity while ensuring stability, making it suitable for procedures where traditional rigid fixation may be too restrictive.
Is the Isobar Semi-Rigid Spinal System reusable or single-use?
The Isobar Semi-Rigid Spinal System is supplied as a reusable device. It is intended for surgical use in controlled clinical environments, where proper sterilization and maintenance protocols can be followed to ensure safety and performance across multiple procedures. Reusability is regulated under FDA Class II standards, ensuring compliance with safety and performance requirements for orthopedic devices.
What regulatory pathway was followed for FDA clearance of this device?
The Isobar Semi-Rigid Spinal System received FDA 510(k) clearance under the Traditional pathway, which demonstrates that it is substantially equivalent to a legally marketed device already on the market. The clearance was granted on November 8, 1999, and the device falls under product code MNI, indicating its classification for spinal fixation and alignment procedures. This pathway ensures that the device meets established safety and performance standards.
How is the Isobar Semi-Rigid Spinal System categorized?
The Isobar Semi-Rigid Spinal System is categorized under product code MNI, which designates it as a spinal fixation and alignment device. This classification aligns with its intended use for spinal stabilization, ensuring it adheres to regulatory guidelines specific to orthopedic devices aimed at correcting spinal deformities or instability. The device is classified as a Class II orthopedic device by the FDA.
What type of clinical environments is this system intended for?
The Isobar Semi-Rigid Spinal System is intended for use in controlled surgical environments, such as operating rooms or specialized orthopedic clinics. These settings provide the necessary infrastructure for proper sterilization, maintenance, and surgical procedures. The reusable nature of the system requires adherence to strict protocols to ensure patient safety and device integrity across multiple uses.