PASS 2 Spinal System
by Medicrea
510(k) K062136
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK062136 | Date6 Oct 2006 | 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- Withdrawn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 PASS 2 Spinal System is a pedicle screw spinal fixation device designed to provide immobilization and stabilization of spinal segments. It consists of pedicle screws, rods, nuts, and clamps to support spinal fusion in skeletally mature patients. This system addresses acute and chronic instabilities or deformities in the thoracic, lumbar, and sacral spine regions, including degenerative spondylolisthesis with neurological impairment.
The device is supplied as a reusable surgical implant and is intended for use in orthopedic procedures. It is regulated under FDA 510(k) clearance (K062136) with a Traditional review pathway, classified under the product code MNI. Sterility and MRI safety specifications are not explicitly stated in the provided data, but it adheres to standard orthopedic surgical practices for spinal fixation.
Other devices from Medicrea
Questions
AI-generated answers, 1 Oct 2026
What is the PASS 2 Spinal System used for?
The PASS 2 Spinal System is designed to immobilize and stabilize spinal segments in skeletally mature patients. It addresses acute or chronic spinal instabilities and deformities, including degenerative spondylolisthesis with neurological impairment, across the thoracic, lumbar, and sacral spine regions. The system helps support spinal fusion procedures by securing screws, rods, nuts, and clamps to maintain proper alignment during healing.
Is the PASS 2 Spinal System reusable or single-use?
The PASS 2 Spinal System is explicitly supplied as a reusable surgical implant. This classification aligns with standard orthopedic practices for spinal fixation devices, allowing for multiple uses in different patients after proper sterilization and maintenance. Reusability helps reduce costs and waste while maintaining reliability for spinal stabilization procedures.
What components does the PASS 2 Spinal System include?
The system comprises pedicle screws, rods, nuts, and clamps. These components work together to anchor the spine securely, enabling proper alignment and stabilization during spinal fusion. The modular design allows for customization based on the patient’s specific anatomical needs, ensuring a tailored fit for thoracic, lumbar, or sacral applications.
How is the PASS 2 Spinal System regulated?
The PASS 2 Spinal System holds FDA 510(k) clearance under the reference number K062136, following a Traditional review pathway. It is classified under product code MNI, which falls under orthopedic spinal fixation devices. This regulatory pathway ensures compliance with safety and effectiveness standards for spinal stabilization implants in the U.S. market.
Are there specific storage requirements for the PASS 2 Spinal System?
While the provided data does not specify exact storage conditions, reusable spinal fixation systems like the PASS 2 typically require adherence to standard orthopedic surgical practices. This includes proper cleaning, sterilization (e.g., autoclaving or ethylene oxide), and storage in a clean, dry environment to prevent contamination or damage. Follow manufacturer guidelines for maintenance to ensure longevity and performance.