The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Arrow Reverse Shoulder Long Keel And Short Keel Glenoid Base.
| Device ID | K142778 |
| 510k Number | K142778 |
| Device Name: | ARROW Reverse Shoulder Long Keel And Short Keel Glenoid Base |
| 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 |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-26 |
| Decision Date | 2015-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661489666582 | K142778 | 000 |
| 03661489644900 | K142778 | 000 |
| 03661489649516 | K142778 | 000 |
| 03661489666483 | K142778 | 000 |
| 03661489666490 | K142778 | 000 |
| 03661489666513 | K142778 | 000 |
| 03661489666520 | K142778 | 000 |
| 03661489666544 | K142778 | 000 |
| 03661489666551 | K142778 | 000 |
| 03661489666575 | K142778 | 000 |
| 03661489641015 | K142778 | 000 |