Arthrex BioSync® Bone Wedge

FDA 510(k) K151256 · Arthex, Inc.

Substantially Equivalent

510(k) numberK151256

Submission

Device name
Arthrex BioSync® Bone Wedge
Applicant
Arthex, Inc.
Naples, FL, US
Received
May 12, 2015
Decision date
August 12, 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
PLF – Bone Wedge
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.

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Questions and answers

When was Arthrex BioSync® Bone Wedge cleared by the FDA?

Arthrex BioSync® Bone Wedge (K151256) received a 510(k) decision of Substantially Equivalent on August 12, 2015, 92 days after the submission was received.

What is the product code of K151256?

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