Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath— 510(k) K230874

Substantially Equivalent

Suzhou Endophix Co., Ltd.

FDA 510(k) clearance K230874 for Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath, Substantially Equivalent on 2023-05-23. Applicant: Suzhou Endophix Co., Ltd..

Clearance details

Applicant: Suzhou Endophix Co., Ltd.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2023-03-30
Decision date: 2023-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

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.