Skip to content

Anterior Spinal Fixation Plate

by Terray Manufacturing, Inc.

510(k) K870085

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK870085 Date30 Jun 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

See all devices from Terray Manufacturing, Inc. →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.