GIBRALT ROD-TO-ROD CROSS CONNECTORS— 510(k) K140645

Substantially Equivalent

Exactech Sarasota

FDA 510(k) clearance K140645 for GIBRALT ROD-TO-ROD CROSS CONNECTORS, Substantially Equivalent on 2014-04-11. Applicant: Exactech Sarasota.

Clearance details

Applicant: Exactech Sarasota
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2014-03-13
Decision date: 2014-04-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Sarasota, FL, US

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Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.