HammerTube System

Pin, Fixation, Smooth

Paragon 28

The following data is part of a premarket notification filed by Paragon 28 with the FDA for Hammertube System.

Pre-market Notification Details

• Device ID: K171715
• 510k Number: K171715
• Device Name: HammerTube System
• Classification: Pin, Fixation, Smooth
• Applicant: Paragon 28 4B Inverness Ct. E., STE 280 Englewood, CO 80112
• Contact: Frank S. Bono
• Correspondent: Karen E. Warden; BackRoads Consulting, Inc PO Box 566 Chesterland, OH 44026 -0566
• Product Code: HTY
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-06-09
• Decision Date: 2018-03-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889795057679	K171715	000
00889795033987	K171715	000
00889795033970	K171715	000
00889795033963	K171715	000
00889795128485	K171715	000
00889795128478	K171715	000
00889795128461	K171715	000
00889795128454	K171715	000
00889795128447	K171715	000
00889795128430	K171715	000
00889795128423	K171715	000
00889795128416	K171715	000
00889795153296	K171715	000
00889795153265	K171715	000
00889795153159	K171715	000
00889795033994	K171715	000
00889795057693	K171715	000
00889795057662	K171715	000
00889795057655	K171715	000
00889795057648	K171715	000
00889795041616	K171715	000
00889795041609	K171715	000
00889795039378	K171715	000
00889795039361	K171715	000
00889795039354	K171715	000
00889795039347	K171715	000
00889795034069	K171715	000
00889795034021	K171715	000
00889795057723	K171715	000
00889795057716	K171715	000
00889795057709	K171715	000
00889795153074	K171715	000