510(k) K090128— TAC-TITE (TM)

Substantially Equivalent

Core Essence Orthopaedics, Inc.

Clearance details

Applicant: Core Essence Orthopaedics, Inc.
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 2009-01-21
Decision date: 2009-03-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Yardley, PA, US

Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

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.