The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Boss Toe Fixation System.
| Device ID | K190261 |
| 510k Number | K190261 |
| Device Name: | BOSS Toe Fixation System |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | Arthrosurface, Inc. 38 Forge Parkway Franklin, MA 02038 |
| Contact | Dawn J. Wilson |
| Correspondent | Dawn J. Wilson Arthrosurface, Inc. 38 Forge Parkway Franklin, MA 02038 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-08 |
| Decision Date | 2019-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M5289CRSD100A0 | K190261 | 000 |
| M5289CRSD200A0 | K190261 | 000 |