TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT— 510(k) K132908

Substantially Equivalent

Medtec, Inc.

FDA 510(k) clearance K132908 for TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT, Substantially Equivalent on 2014-03-04. Applicant: Medtec, Inc..

Clearance details

Applicant: Medtec, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2013-09-17
Decision date: 2014-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange City, IA, US

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.