Vertebron PSS Pedicle Screw System
510(k) K033352
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033352 | Date25 Feb 2004 | 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- Withdrawn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 Vertebron PSS Pedicle Screw System is a spinal fixation device classified as a pedicle screw system for non-cervical vertebrae. It consists of screws designed to anchor into the vertebral body, enabling surgeons to construct a stable spinal implant construct for surgical stabilization. This system is intended for use in spinal fusion procedures to correct spinal deformities or instability. Its design facilitates secure attachment to the spine, aiding in the alignment and support of the vertebral column during recovery.
The system is supplied as a reusable surgical implant and is intended for use in clinical settings by trained orthopedic surgeons. Components are sterilized for single-use implantation, adhering to standard medical device sterilization protocols. The device is regulated under FDA 510(k) clearance (K033352) as a Class 2 Orthopedic device, with product code MNI. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality prior to surgical use.
Other devices from Vertebron, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Vertebron PSS Pedicle Screw System used for?
The Vertebron PSS Pedicle Screw System is designed for spinal fusion procedures to correct spinal deformities or instability in non-cervical vertebrae. It provides secure fixation by anchoring screws into the vertebral body, enabling surgeons to construct a stable spinal implant construct. This helps maintain proper alignment and support of the spine during the healing process.
Is the Vertebron PSS Pedicle Screw System reusable or single-use?
The system itself is reusable for surgical use, but the individual screws are intended for single-use implantation. This ensures sterility and compliance with medical device protocols, as the screws are sterilized specifically for one-time surgical application.
How should the Vertebron PSS Pedicle Screw System be stored?
Storage and handling must follow the manufacturer’s guidelines to preserve sterility and functionality. Since the screws are sterilized for single-use, they should be stored in their original packaging until immediately before use. The reusable components should be cleaned and maintained according to established surgical instrument protocols.
What regulatory approval does the Vertebron PSS Pedicle Screw System hold?
The device holds FDA 510(k) clearance (K033352) as a Class 2 Orthopedic device under product code MNI. This clearance confirms it is deemed substantially equivalent to a legally marketed predicate device, meeting regulatory standards for spinal fixation systems.
Can this system be used for cervical vertebrae procedures?
No, the Vertebron PSS Pedicle Screw System is specifically intended for non-cervical vertebrae. Its design and anchoring mechanism are optimized for thoracic and lumbar regions, where spinal fusion procedures are most commonly performed for deformity correction or instability.