Zimmer Motionloc Screw for Periarticular Locking Plate System

FDA 510(k) K130810 · Zimmer, Inc.

Substantially Equivalent

510(k) numberK130810

Submission

Device name
Zimmer Motionloc Screw for Periarticular Locking Plate System
Applicant
Zimmer, Inc.
Indianpolis, IN, US
Received
March 25, 2013
Decision date
September 19, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HWC – Screw, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was Zimmer Motionloc Screw for Periarticular Locking Plate System cleared by the FDA?

Zimmer Motionloc Screw for Periarticular Locking Plate System (K130810) received a 510(k) decision of Substantially Equivalent on September 19, 2013, 178 days after the submission was received.

What is the product code of K130810?

The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.