The following data is part of a premarket notification filed by Arthrosurface Inc. with the FDA for Hemicap Humeral Head Xl (hhxl) Articular Resurfacing System.
| Device ID | K142942 |
| 510k Number | K142942 |
| Device Name: | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| 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 | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-14 |
| Decision Date | 2014-12-19 |
| Summary: | summary |