FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire— 510(k) K190125

Substantially Equivalent

T.A.G. Medical Products Corporation, Ltd.

FDA 510(k) clearance K190125 for FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire, Substantially Equivalent on 2019-05-19. Applicant: T.A.G. Medical Products Corporation, Ltd..

Clearance details

Applicant: T.A.G. Medical Products Corporation, Ltd.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2019-01-28
Decision date: 2019-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaaton, IL

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.