Bio2 Fusion Implant System

FDA 510(k) K151876 · Bio2 Technologies, Inc.

Substantially Equivalent

510(k) numberK151876

Submission

Device name
Bio2 Fusion Implant System
Applicant
Bio2 Technologies, Inc.
Woburn, MA, US
Received
July 9, 2015
Decision date
December 30, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HTY – Pin, Fixation, Smooth
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was Bio2 Fusion Implant System cleared by the FDA?

Bio2 Fusion Implant System (K151876) received a 510(k) decision of Substantially Equivalent on December 30, 2015, 174 days after the submission was received.

What is the product code of K151876?

The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.