ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES

Plate, Fixation, Bone

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Periarticular Locking Plate System: Distal Humeral And Proximal Ulna Plates.

Pre-market Notification Details

• Device ID: K082078
• 510k Number: K082078
• Device Name: ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES
• Classification: Plate, Fixation, Bone
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Anthony Francalancia
• Correspondent: Anthony Francalancia; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-07-23
• Decision Date: 2008-11-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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