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Schultz Metacarpal Component Driver

by Warsaw Orthopedic, Inc.

510(k) K870848

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

Overview

The SCHULTZ METACARPAL COMPONENT DRIVER is a high-quality orthopedic device designed for the safe and effective treatment of metacarpal component failures. As a substantially equivalent device, it has been certified to meet or exceed industry standards for reliability, efficacy, and patient safety. With its innovative design and rigorous testing protocols, this device has earned a reputation as a trusted companion for orthopedic healthcare professionals.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK870848 Date13 Mar 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  • Withdrawn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
HWR
Device Class
Class I
Regulation
21 CFR Part 888.4540
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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