Cleared Traditional

K171568 - SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty (FDA 510(k) Clearance)

K171568 · Hans Biomed Corporation · Orthopedic device

Feb 2018

Decision

268d

Days

Class 2

Risk

K171568 is an FDA 510(k) clearance for the SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Hans Biomed Corporation (Daejeon, KR). The FDA issued a Cleared decision on February 22, 2018, 268 days after receiving the submission on May 30, 2017.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number	K171568 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 30, 2017
Decision Date	February 22, 2018
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF