CONNEXX LOCKING TIBIA NAIL— 510(k) K080706

Substantially Equivalent

I.T.S. Implantat-Technologie-Systeme GmbH

FDA 510(k) clearance K080706 for CONNEXX LOCKING TIBIA NAIL, Substantially Equivalent on 2008-06-09. Applicant: I.T.S. Implantat-Technologie-Systeme GmbH.

Clearance details

Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
Product code: Code JDS
Advisory panel: Orthopedic
Date received: 2008-03-12
Decision date: 2008-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Prior Lake, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDS

product code JDS

Injury: 1,776
Malfunction: 1,509
Total: 3,285

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.