The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Arrow Reverse Shoulder System.
| Device ID | K112193 |
| 510k Number | K112193 |
| Device Name: | ARROW REVERSE SHOULDER SYSTEM |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000 |
| Contact | Patricia Donnard |
| Correspondent | Patricia Donnard FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000 |
| Product Code | PHX |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-29 |
| Decision Date | 2012-07-12 |
| Summary: | summary |