Company · US
Aurora Spine, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2025. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PEK | Spinous Process Plate | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 |
| MRW | System, Facet Screw Spinal Device | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 |
| OUR | Sacroiliac Joint Fixation | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 24, 2025 | K243865 | AERO MIS Facet Fusion System Aurora Spine | MRW |
| Oct 3, 2022 | K221047 | SILO TFX MIS Sacroiliac Joint Fixation System Aurora Spine, Inc. | OUR |
| Jul 8, 2022 | K221399 | ZIP MIS Interspinous Fusion System Aurora Spine, Inc. | PEK |
| May 27, 2022 | K220610 | SOLO-L Aurora Spine, Inc. | OVD |
| Aug 2, 2021 | K210521 | DEXA-C Cervical Interbody System Aurora Spine, Inc. | ODP |
| Mar 23, 2021 | K210325 | APOLLO Anterior Cervical Plate (ACP) System Aurora Spine, Inc. | KWQ |
| Nov 17, 2014 | K141317 | ZIP MIS INTERSPINOUS FUSION SYSTEM Aurora Spine, Inc. | PEK |
| Apr 17, 2014 | K140715 | ZIP MIS INTERSPINOUS FUSION SYSTEM Aurora Spine, Inc. | PEK |
| Jan 31, 2014 | K133967 | INTERBODY CAGE SYSTEM Aurora Spine | MAX |
| Nov 27, 2013 | K133091 | ZIP MIS INTERSPINOUS FUSION SYSTEM Aurora Spine | PEK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||