Modificaton to: Zimmer Periarticular Locking Plates and Screws

FDA 510(k) K070906 · Zimmer, Inc.

Substantially Equivalent

510(k) numberK070906

Submission

Device name
Modificaton to: Zimmer Periarticular Locking Plates and Screws
Applicant
Zimmer, Inc.
Warsaw, IN, US
Received
April 2, 2007
Decision date
May 1, 2007
Decision
Substantially Equivalent (SESE)
Type
Special 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 Modificaton to: Zimmer Periarticular Locking Plates and Screws cleared by the FDA?

Modificaton to: Zimmer Periarticular Locking Plates and Screws (K070906) received a 510(k) decision of Substantially Equivalent on May 1, 2007, 29 days after the submission was received.

What is the product code of K070906?

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