OASYS System
by Stryker Corporation 3 variants
510(k) K150539
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150539 | Date12 May 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- Withdrawn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
- NKG
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3075
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The OASYS System is a modular spinal system designed to aid in spine fusion. It consists of screws, hooks, plates, rods, and connectors, and is indicated for conditions such as degenerative disc disease, spondylolisthesis, spinal stenosis, fractures, and tumors.
The system is supplied as a comprehensive product line with an array of occipital plates and bone screws. It is intended for use in the occipito-cervico-thoracic spine and is authorized under FDA 510K clearance with product code NKG.
Other devices from Stryker Corp.
Questions
AI-generated answers, 22 Sep 2026
What is the OASYS System used for?
The OASYS System is a modular spinal system designed to aid in spine fusion procedures. It is indicated for conditions such as degenerative disc disease, spondylolisthesis, spinal stenosis, fractures, and tumors in the occipito-cervico-thoracic spine.
What components are included in the OASYS System?
The OASYS System consists of screws, hooks, plates, rods, and connectors. It is supplied as a comprehensive product line with an array of occipital plates and bone screws to accommodate various surgical needs.
What is the regulatory status of the OASYS System?
The OASYS System is authorized under FDA 510K clearance with product code NKG. It received traditional clearance on May 12, 2015, with a decision code of SESE, indicating it is substantially equivalent to predicate devices.
Is the OASYS System reusable or single-use?
The device data does not specify whether the OASYS System is reusable or single-use. This information would typically be found in the product's instructions for use, which should be consulted for proper handling and sterilization procedures.