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

Clearance details

Applicant

Suzhou Endophix Co., Ltd.

Product code

Code MBI

Device class

Class 2

Regulation

21 CFR 888.3040

Advisory panel

Orthopedic

Date received

2023-03-30

Decision date

2023-05-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Suzhou, CN

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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 →