The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Arrow Anatomical Porous Glenoid.
| Device ID | K162068 |
| 510k Number | K162068 |
| Device Name: | ARROW Anatomical Porous Glenoid |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| 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 | MBF |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-26 |
| Decision Date | 2017-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661489692963 | K162068 | 000 |
| 03661489671128 | K162068 | 000 |
| 03661489668395 | K162068 | 000 |
| 03661489668388 | K162068 | 000 |
| 03661489668364 | K162068 | 000 |
| 03661489668357 | K162068 | 000 |
| 03661489668340 | K162068 | 000 |
| 03661489668333 | K162068 | 000 |
| 03661489654237 | K162068 | 000 |
| 03661489654145 | K162068 | 000 |
| 03661489644726 | K162068 | 000 |
| 03661489644610 | K162068 | 000 |
| 03661489673528 | K162068 | 000 |
| 03661489673535 | K162068 | 000 |
| 03661489691317 | K162068 | 000 |
| 03661489690662 | K162068 | 000 |
| 03661489690655 | K162068 | 000 |
| 03661489690648 | K162068 | 000 |
| 03661489690631 | K162068 | 000 |
| 03661489690624 | K162068 | 000 |
| 03661489687358 | K162068 | 000 |
| 03661489687280 | K162068 | 000 |
| 03661489678202 | K162068 | 000 |
| 03661489676499 | K162068 | 000 |
| 03661489676482 | K162068 | 000 |
| 03661489644603 | K162068 | 000 |