Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K181350
ASTRA-OCT Spine System · Spinecraft, LLC · decided 2018-07-06 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ASTRA-OCT Spine System | A3H-RO55 | SPINECRAFT, LLC | KWP NKG | 00193082110191 |
| ASTRA-OCT Spine System | A3R-T34-325K | SPINECRAFT, LLC | KWP NKG | 00193082109645 |
| ASTRA-OCT Spine System | A3P-5520R | SPINECRAFT, LLC | KWP NKG | 00193082108150 |
| ASTRA-OCT Spine System | A3P-4028 | SPINECRAFT, LLC | KWP NKG | M824A3P40281 |
| ASTRA-OCT Spine System | A3C | SPINECRAFT, LLC | KWP NKG | M824A3C1 |
| ASTRA-OCT Spine System | A3OR-40-9030K | SPINECRAFT, LLC | KWP NKG | 00193082110047 |
| ASTRA-OCT Spine System | A3R-T44-500K | SPINECRAFT, LLC | KWP NKG | 00193082109942 |
| ASTRA-OCT Spine System | A3R-35-090 | SPINECRAFT, LLC | KWP NKG | 00193082109003 |
| ASTRA-OCT Spine System | A3P-4032R-S | SPINECRAFT, LLC | KWP NKG | 00193082108808 |
| ASTRA-OCT Spine System | A3P-4020R-S | SPINECRAFT, LLC | KWP NKG | 00193082108747 |
| ASTRA-OCT Spine System | A3P-3536-S | SPINECRAFT, LLC | KWP NKG | 00193082108310 |
| ASTRA-OCT Spine System | A3P-4522 | SPINECRAFT, LLC | KWP NKG | 00193082107122 |
| ASTRA-OCT Spine System | A3P-4536R | SPINECRAFT, LLC | KWP NKG | M824A3P4536R1 |
| ASTRA-OCT Spine System | A3P-4530R | SPINECRAFT, LLC | KWP NKG | M824A3P4530R1 |
| ASTRA-OCT Spine System | A3P-5535R | SPINECRAFT, LLC | KWP NKG | 00193082108181 |
| ASTRA-OCT Spine System | A3R-T44-325K | SPINECRAFT, LLC | KWP NKG | M824A3RT44325K1 |
| ASTRA-OCT Spine System | A3R-40-300K | SPINECRAFT, LLC | KWP NKG | M824A3R40300K1 |
| ASTRA-OCT Spine System | A3R-35-045 | SPINECRAFT, LLC | KWP NKG | M824A3R350451 |
| ASTRA-OCT Spine System | A3P-5540 | SPINECRAFT, LLC | KWP NKG | M824A3P55401 |
| ASTRA-OCT Spine System | A3P-5015R | SPINECRAFT, LLC | KWP NKG | M824A3P5015R1 |
| ASTRA-OCT Spine System | A3P-4036-S | SPINECRAFT, LLC | KWP NKG | M824A3P4036S1 |
| ASTRA-OCT Spine System | A3P-4534R | SPINECRAFT, LLC | KWP NKG | 00193082107979 |
| ASTRA-OCT Spine System | A3P-5015 | SPINECRAFT, LLC | KWP NKG | 00193082107276 |
| ASTRA-OCT Spine System | A3P-4028 | SPINECRAFT, LLC | KWP NKG | 00193082106941 |
| ASTRA-OCT Spine System | A3R-40-300 | SPINECRAFT, LLC | KWP NKG | M824A3R403001 |