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Chiba Spinal System

by Danek Medical, Inc. 510(k)

Active United States

510(k) K895978

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895978 Date9 Aug 1990ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 21 Sep 2026

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

The Chiba Spinal System is a spinal system device. It is identified by the device name CHIBA SPINAL SYSTEM and product code KWP.

The device received FDA 510(k) clearance under K895978, with a decision date of 1990-08-09. It was determined to be substantially equivalent and reviewed by the Orthopedic advisory committee. The applicant is Danek Medical, Inc., located in Memphis, TN.

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