VariAx 2 Foot System

FDA 510(k) K170771 · Stryker GmbH

Substantially Equivalent

510(k) numberK170771

Submission

Device name
VariAx 2 Foot System
Applicant
Stryker GmbH
Mahwah, NJ, US
Received
March 14, 2017
Decision date
May 8, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HRS – Plate, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was VariAx 2 Foot System cleared by the FDA?

VariAx 2 Foot System (K170771) received a 510(k) decision of Substantially Equivalent on May 8, 2017, 55 days after the submission was received.

What is the product code of K170771?

The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.