The following data is part of a premarket notification filed by Paragon 28 with the FDA for Hammertube System.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00889795057679 | K171715 | 000 |
00889795057693 | K171715 | 000 |
00889795033994 | 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 |
00889795057709 | K171715 | 000 |
00889795057716 | 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 |
00889795128416 | K171715 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HAMMERTUBE SYSTEM 87715733 5464721 Live/Registered |
PARAGON 28, INC. 2017-12-11 |