Reliance Spinal Screw System
by Reliance Medical Systems, LLC 7 variants
510(k) K152131
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152131 | Date17 Sep 2015 | 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- Withdrawn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 Reliance Spinal Screw System is a pedicle screw assembly designed for spinal stabilization. It is classified as an orthopedic implant intended to immobilize and stabilize spinal segments in skeletally mature patients as an adjunct to spinal fusion. The system addresses acute and chronic spinal instabilities or deformities, including degenerative spondylolisthesis with neurological impairment, in the thoracic, lumbar, and sacral regions.
This system is supplied as a non-sterile, implantable device and requires sterilization prior to use. It is intended for single-patient use and must be handled under sterile conditions in an operating room or surgical suite. The device is FDA-cleared under 510(k) classification (K152131) and falls under the product code MNI for orthopedic spinal fixation. Storage and handling must comply with medical device sterilization protocols.
Other devices from Reliance Medical Systems, LLC
Questions
AI-generated answers, 1 Oct 2026
What is the Reliance Spinal Screw System used for?
The Reliance Spinal Screw System is designed for spinal stabilization in skeletally mature patients as an adjunct to spinal fusion. It addresses acute and chronic spinal instabilities or deformities, including degenerative spondylolisthesis with neurological impairment, across the thoracic, lumbar, and sacral regions. The system helps immobilize and stabilize spinal segments to promote proper healing and alignment.
How is the Reliance Spinal Screw System supplied and prepared for use?
The system is supplied in a non-sterile state and must be sterilized prior to surgical use. It is intended for single-patient use only, meaning each assembly should not be reused. Sterilization and handling must occur under sterile conditions in an operating room or surgical suite to ensure patient safety and device integrity.
Is the Reliance Spinal Screw System reusable or single-use?
The Reliance Spinal Screw System is explicitly intended for single-patient use. This designation ensures patient safety by preventing cross-contamination and maintaining device sterility. Reuse is not recommended or approved for this system.
What sterilization protocols should be followed for storage and handling?
Storage and handling of the Reliance Spinal Screw System must comply with established medical device sterilization protocols. Since the system is non-sterile upon receipt, it requires proper sterilization before use. Always follow facility-specific guidelines for sterilization methods (e.g., autoclave, ethylene oxide) and storage conditions to preserve device integrity and ensure sterility.
What regulatory approval does the Reliance Spinal Screw System hold?
The Reliance Spinal Screw System has received FDA clearance under the 510(k) classification with the clearance number K152131. It is categorized under product code MNI for orthopedic spinal fixation and is classified as substantially equivalent to a predicate device. This clearance confirms its compliance with U.S. regulatory standards for spinal stabilization implants.