The following data is part of a premarket notification filed by Arthrosurface, Inc with the FDA for Kissloc Suture System.
Device ID | K170440 |
510k Number | K170440 |
Device Name: | KISSloc Suture System |
Classification | Washer, Bolt Nut |
Applicant | Arthrosurface, Inc 28 Forge Parkway Franklin, MA 02038 |
Contact | Dawn J. Wilson |
Correspondent | Dawn J. Wilson Arthrosurface, Inc 28 Forge Parkway Franklin, MA 02038 |
Product Code | HTN |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-14 |
Decision Date | 2017-05-03 |
Summary: | summary |