Zimmer Plates And Screws (ZPS), Forte Screws

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), Forte Screws.

Pre-market Notification Details

• Device ID: K142836
• 510k Number: K142836
• Device Name: Zimmer Plates And Screws (ZPS), Forte Screws
• Classification: Plate, Fixation, Bone
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Patrick Mccullagh
• Correspondent: Stephen H Mckelvey; 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: 2014-09-30
• Decision Date: 2014-11-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024510654	K142836	000
00889024510821	K142836	000
00889024510838	K142836	000
00889024510845	K142836	000
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00889024062566	K142836	000
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00889024062474	K142836	000
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00889024062498	K142836	000
00889024062665	K142836	000