STRYKER EXTERNAL FIXATION SYSTEM— 510(k) K071628

Name: FDA 510(k) clearance K071628
Creator: U.S. Food and Drug Administration
Published: 2007-08-10

Substantially Equivalent

Stryker Cmf

FDA 510(k) clearance K071628 for STRYKER EXTERNAL FIXATION SYSTEM, Substantially Equivalent on 2007-08-10. Applicant: Stryker Cmf. Device class: 2.

Clearance details

Applicant: Stryker Cmf
Product code: Code MQN
Device class: Class 2
Regulation: 21 CFR 872.4760
Advisory panel: Dental
Date received: 2007-06-14
Decision date: 2007-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQN

view all

K220050 — KLS Martin IPS Distraction2022-08-11
K183113 — DePuy Synthes Maxillofacial Portfolio - MR Conditional2019-03-13
K181504 — Stryker Pediatric Mandibular Distractor 22018-09-11
K162594 — Craniomaxillofacial Distraction System (CMFD)2017-05-08
K161470 — Internal Distraction - Sterile2016-12-01

More clearances from Stryker Cmf

view all

K060750 — STRYKER INJECTABLE CEMENT2006-04-19

Adverse events under product code MQN

product code MQN

Injury: 346
Total: 346

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.