UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS

Screw, Fixation, Bone

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Universal Locking System, 3.5mm Plates And Screws-4936 Plates,4835 Screws.

Pre-market Notification Details

• Device ID: K060710
• 510k Number: K060710
• Device Name: UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS
• Classification: Screw, 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: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-03-16
• Decision Date: 2006-04-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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