RECON system-V-TEK-IVP Plates and Screws— 510(k) K152312

Substantially Equivalent

Normed Medizin-Technik GmbH

FDA 510(k) clearance K152312 for RECON system-V-TEK-IVP Plates and Screws, Substantially Equivalent on 2015-10-30. Applicant: Normed Medizin-Technik GmbH.

Clearance details

Applicant: Normed Medizin-Technik GmbH
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2015-08-17
Decision date: 2015-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.