Anterior Spinal Fixation Plate
510(k) K870085
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870085 | Date30 Jun 1987 | 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- Withdrawn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
- KWP
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Anterior Spinal Fixation Plate is a device intended to immobilize the spine and allow bone grafts to unite and fuse the vertebrae together. It is made of an alloy, such as stainless steel, and consists of various components that are implanted, usually across adjacent vertebrae, to straighten and stabilize the spine.
The device is supplied as a single unit and is intended for use in orthopedic applications. It has been authorized with an FDA 510K clearance, specifically with the decision code SESE, and has been classified under the product code KWP. The device is manufactured by Terray Manufacturing, Inc. and has a unique k number, K870085.
Other devices from Terray Manufacturing, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the Anterior Spinal Fixation Plate used for?
The Anterior Spinal Fixation Plate is used to immobilize the spine and allow bone grafts to unite and fuse the vertebrae together, providing stability and straightening the spine.
How is the device supplied?
The Anterior Spinal Fixation Plate is supplied as a single unit, intended for use in orthopedic applications.
What material is the device made of?
The device is made of an alloy, such as stainless steel.
Is the device intended for single or multiple uses?
The device is intended for implantation, usually across adjacent vertebrae, and is not specified as single-use or reusable.