THE GRAPPLR AND GRAPPLR EXTENDER— 510(k) K101616

Substantially Equivalent

Tag Medical Corp.

FDA 510(k) clearance K101616 for THE GRAPPLR AND GRAPPLR EXTENDER, Substantially Equivalent on 2011-01-06. Applicant: Tag Medical Corp..

Clearance details

Applicant: Tag Medical Corp.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2010-06-09
Decision date: 2011-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.