SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty— 510(k) K171568

Clearance details

Applicant

Hans Biomed Corporation

Product code

Code MQV

Device class

Class 2

Regulation

21 CFR 888.3045

Advisory panel

Orthopedic

Date received

2017-05-30

Decision date

2018-02-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Daejeon, KR

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Death

6

Injury

435

Total

441

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 →