MRP-TITAN— 510(k) K992403

Substantially Equivalent

Rotec Medizintechnik GmbH

FDA 510(k) clearance K992403 for MRP-TITAN, Substantially Equivalent on 2000-01-21. Applicant: Rotec Medizintechnik GmbH.

Clearance details

Applicant: Rotec Medizintechnik GmbH
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 1999-07-19
Decision date: 2000-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weisendorf, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.