ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM)

Plate, Fixation, Bone

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Universal Locking System 2.7 Mm Locking Plates And Screws ( Tivanium Ti-6a1-4v Alloy, Cp Grade Titanium).

Pre-market Notification Details

• Device ID: K083654
• 510k Number: K083654
• Device Name: ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM)
• 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: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-10
• Decision Date: 2009-02-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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