Cleared Traditional

K181504 - Stryker Pediatric Mandibular Distractor 2
(FDA 510(k) Clearance)

K181504 · Stryker · Dental

Sep 2018

Decision

96d

Days

Class 2

Risk

K181504 is an FDA 510(k) clearance for the Stryker Pediatric Mandibular Distractor 2, a External Mandibular Fixator And/or Distractor (Class II — Special Controls, product code MQN), submitted by Stryker (Portage, US). The FDA issued a Cleared decision on September 11, 2018, 96 days after receiving the submission on June 7, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number	K181504 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 07, 2018
Decision Date	September 11, 2018
Days to Decision	96 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF