Kirschner Wires, Steinmann Pins

Pin, Fixation, Smooth

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Kirschner Wires, Steinmann Pins.

Pre-market Notification Details

• Device ID: K143618
• 510k Number: K143618
• Device Name: Kirschner Wires, Steinmann Pins
• Classification: Pin, Fixation, Smooth
• 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: HTY
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-12-19
• Decision Date: 2015-02-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024076457	K143618	000
00889024084346	K143618	000
00889024084353	K143618	000
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00889024021730	K143618	000