SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE— 510(k) K081598

Substantially Equivalent

Kfx Medical

FDA 510(k) clearance K081598 for SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE, Substantially Equivalent on 2008-07-03. Applicant: Kfx Medical.

Clearance details

Applicant: Kfx Medical
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2008-06-06
Decision date: 2008-07-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Carlsbad, CA, 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.