The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Arthrosurface Kissloc Knotless Suture System.
| Device ID | K133835 |
| 510k Number | K133835 |
| Device Name: | ARTHROSURFACE KISSLOC KNOTLESS 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 | 2013-12-18 |
| Decision Date | 2014-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M5289V0002000 | K133835 | 000 |
| M5289V0001000 | K133835 | 000 |