BONE PLATES— 510(k) K843553

Name: FDA 510(k) clearance K843553
Creator: U.S. Food and Drug Administration
Published: 1984-10-01

Substantially Equivalent

Mecron Medical Products, Inc.

FDA 510(k) clearance K843553 for BONE PLATES, Substantially Equivalent on 1984-10-01. Applicant: Mecron Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Mecron Medical Products, Inc.
Product code: Code KTW
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1984-09-10
Decision date: 1984-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KTW

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K182285 — PK High Tibial Osteotomy Correction System2019-06-20
K171606 — AOS Anterolateral Proximal Humeral Plate2017-06-22
K170693 — Phantom Small Bone Intramedullary Nail System2017-06-19
K160409 — AOS Anterolateral Proximal Humeral Plate2016-03-15
K122541 — ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)2012-09-20

More clearances from Mecron Medical Products, Inc.

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K861138 — MASH DERMATOME1986-04-14
K854191 — MECRON UNCEMENTED STRUCTURED STEM HIP1985-11-13
K844775 — EFFNER-EYE CAUTERY WITH BATTERY HANDLE1985-08-12
K844774 — EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS1985-04-22
K844488 — MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS1985-03-12

Adverse events under product code KTW

product code KTW

Injury: 220
Total: 220

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.