PATHWAY
by Custom Spine, Inc. 510(k)
Active
510(k) K080281
Overview
The PATHWAY is an orthopedic device classified as a Class 2 medical device with product code MAX. It is a vertebral interbody device designed for spinal implantation.
The device was cleared through the FDA 510(k) Traditional pathway under K080281, determined to be substantially equivalent to a predicate device. It is manufactured by Custom Spine, Inc. and authorized for distribution in the United States.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK080281 | Date1 May 2008 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MAX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Custom Spine, Inc.
Questions
What is the PATHWAY device used for?
The PATHWAY is a vertebral interbody device designed for spinal implantation, intended to support spinal fusion procedures by maintaining disc space and promoting bone growth between vertebrae.
How is the PATHWAY device supplied and is it sterile?
The PATHWAY device is supplied sterile for single-use implantation; it is manufactured and packaged to maintain sterility until point of use, ensuring it meets surgical safety standards for spinal procedures.
What regulatory pathway was used for the PATHWAY device clearance?
The PATHWAY device received FDA 510(k) clearance through the Traditional pathway under K080281, where it was determined to be substantially equivalent to a legally marketed predicate device.