Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K213935
PISCES-SA Standalone ALIF Interbody System · Osseus Fusion Systems · decided 2022-05-06 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Pisces-SA | 1700-L112S | Osseus Fusion Systems, LLC | MAX OVD PHM | B0621700L112 |
| Pisces-SA | 1750-L116 | Osseus Fusion Systems, LLC | FZX | B0621750L116 |
| Pisces-SA | 1720-5038 | Osseus Fusion Systems, LLC | OVD | B06217205038 |
| Pisces-SA | 1750-0001 | Osseus Fusion Systems, LLC | MAX OVD PHM | B06217500001 |
| Pisces-SA | 1700-S136S | Osseus Fusion Systems, LLC | MAX OVD PHM | B0621700S136 |
| Pisces-SA | 1760-7049 | Osseus Fusion Systems, LLC | HTX | B06217607049 |
| Pisces-SA | 1760-7030 | Osseus Fusion Systems, LLC | FZS | B06217607030 |
| Pisces-SA | 1760-7096 | Osseus Fusion Systems, LLC | LXH | B06217607096 |
| Pisces-SA | 1700-M152S | Osseus Fusion Systems, LLC | MAX OVD PHM | B0621700M152 |
| Pisces-SA | 1700-L098S | Osseus Fusion Systems, LLC | MAX OVD PHM | B0621700L098 |
| Pisces-SA | 1760-7103 | Osseus Fusion Systems, LLC | HWM | B06217607103 |
| Pisces-SA | 1760-7012 | Osseus Fusion Systems, LLC | FZS | B06217607012 |
| Pisces-SA | 1750-S192 | Osseus Fusion Systems, LLC | FZX | B0621750S192 |
| Pisces-SA | 1750-M156 | Osseus Fusion Systems, LLC | FZX | B0621750M156 |
| Pisces-SA | 1700-S178 | Osseus Fusion Systems, LLC | MAX OVD PHM | B0621700S178 |
| Pisces-SA | 1750-0054 | Osseus Fusion Systems, LLC | HWX | B06217500054 |
| Pisces-SA | 1760-7073 | Osseus Fusion Systems, LLC | HTX | B06217607073 |
| Pisces-SA | 1750-S116 | Osseus Fusion Systems, LLC | FZX | B0621750S116 |
| Pisces-SA | 1760-7043 | Osseus Fusion Systems, LLC | HTX | B06217607043 |
| Pisces-SA | 1760-7003 | Osseus Fusion Systems, LLC | GEG | B06217607003 |
| Pisces-SA | 1720-5133 | Osseus Fusion Systems, LLC | OVD | B06217205133 |
| Pisces-SA | 1700-L130S | Osseus Fusion Systems, LLC | MAX OVD PHM | B0621700L130 |
| Pisces-SA | 1760-7079 | Osseus Fusion Systems, LLC | HTX | B06217607079 |
| Pisces-SA | 1750-0016 | Osseus Fusion Systems, LLC | LXH | B06217500016 |
| Pisces-SA | 1720-0001 | Osseus Fusion Systems, LLC | OVD | B06217200001 |