Zimmer Plates And Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws And Washers

Plate, Fixation, Bone

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Plates And Screws (zps) - Non Sterile Plate Line Extensions, Sterile/non-sterile Zps / Screws And Washers.

Pre-market Notification Details

• Device ID: K143066
• 510k Number: K143066
• Device Name: Zimmer Plates And Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws And Washers
• Classification: Plate, Fixation, Bone
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Patrick Mcullagh
• Correspondent: Stephen H. Mckelvey; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: HRS
• Subsequent Product Code: HTN
• Subsequent Product Code: HWC
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-10-24
• Decision Date: 2014-11-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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