Total clearances
5
2020-01-17 → 2023-02-10
Name variants in FDA filings: Osseus Fusion Systems, LLC / Osseus Fusion Systems
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| OVD |
Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Class II |
Orthopedic |
2 |
2023-02-10 |
| NKG |
Posterior Cervical Screw System |
Class II |
Orthopedic |
1 |
2022-11-03 |
| OUR |
Sacroiliac Joint Fixation |
Class II |
Orthopedic |
1 |
2022-03-01 |
| OLO |
Orthopedic Stereotaxic Instrument |
Class II |
Neurology |
1 |
2020-01-17 |
Filings
All 510(k) clearances (5)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2023-02-10 |
K223413 |
Pisces-SA STANDALONE ALIF Interbody System |
OVD |
Class II |
Orthopedic |
| 2022-11-03 |
K222107 |
Black Diamond POCT Spinal System |
NKG |
Class II |
Orthopedic |
| 2022-05-06 |
K213935 |
PISCES-SA Standalone ALIF Interbody System |
OVD |
Class II |
Orthopedic |
| 2022-03-01 |
K213590 |
Blue Topaz Sacroiliac Screw System |
OUR |
Class II |
Orthopedic |
| 2020-01-17 |
K192495 |
Black Diamond Navigation Instruments |
OLO |
Class II |
Neurology |