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Bradford Spinal Fracture Fixation Sys

by Depuy, Inc. 510(k)

Active United States

510(k) K831982

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK831982 Date20 Sep 1983ClearedStatusActive

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  • Withdrawn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
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

This is an orthopedic device for spinal fracture fixation. It is substantially equivalent to a predicate device and cleared through the traditional 510(k) pathway.

The device is supplied by Depuy, Inc. It is a Class 2 device with product code KWQ and authorization under FDA 510(k) K831982. It was cleared on September 20, 1983, following a 92-day review.

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