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Vsp System

by Medical Modeling, Inc. 2 variants

510(k) K133907

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 · Special NumberK133907 Date22 Jan 2014ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1510-2022 FDA Class II initiated 17 May 2022

    Scapula Marking Guide (anatomically Shaped) was incorrectly designed.

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  • Withdrawn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
DZJ
Device Class
Class II
Regulation
21 CFR Part 872.4120
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from Medical Modeling, Inc.

  • Vsp System

    Class II