The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Cap Great Toe Resurfacing Hemi-arthroplasty Implant.
| Device ID | K031859 |
| 510k Number | K031859 |
| Device Name: | CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | ARTHROSURFACE, INC. 378 PAGE STREET, STE 6 Stoughton, MA 02072 |
| Contact | Robert J Michalik |
| Correspondent | Robert J Michalik ARTHROSURFACE, INC. 378 PAGE STREET, STE 6 Stoughton, MA 02072 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-16 |
| Decision Date | 2004-02-18 |
| Summary: | summary |