Osseus Fusion Systems LLC
Dallas, TX, US
OSSEUS FUSION SYSTEMS LLC appears in FDA device records in Dallas, TX. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Osseus Fusion Systems LLC between 2013 and 2023. The busiest year on record is 2022, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 3 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223413 | Pisces™-SA STANDALONE ALIF Interbody System | OVD | Substantially Equivalent | |
| K222107 | Black Diamond™ POCT Spinal System | NKG | Substantially Equivalent | |
| K213935 | PISCES-SA Standalone ALIF Interbody System | OVD | Substantially Equivalent | |
| K213590 | Blue Topaz Sacroiliac Screw System | OUR | Substantially Equivalent | |
| K192495 | Black Diamond Navigation Instruments | OLO | Substantially Equivalent | |
| K192121 | Black Diamond Pedicle Screw System | NKB | Substantially Equivalent | |
| K181347 | Aries® Lumbar Interbodies | MAX | Substantially Equivalent | |
| K170844 | Gemini-C Hybrid Cervical Interbody System | ODP | Substantially Equivalent | |
| K160522 | White Pearl Preferred Angle Anterior Cervical Plate | KWQ | Substantially Equivalent | |
| K131810 | OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM | MNH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010531060 | 3010531060 | OSSEUS FUSION SYSTEMS LLC | 1931 Greenville Avenue, Dallas, TX 75206 US | 2026 | and 26 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HXNApplier, Cerclage
- HWJAwl
- HXWBender
- HTWBit, Drill
- KTZCaliper
- HXQCrimper, Pin
- HTFCurette
- HYAForceps, Wire Holding
- FZXGuide, Surgical, Instrument
- HXPInstrument, Bending Or Contouring
- HWNInstrument, Compression
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- PHMIntervertebral Fusion Device With Bone Graft, Thoracic
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- HXLMallet
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HTCPliers, Surgical
- NKGPosterior Cervical Screw System
- HXBProbe
- HTRRasp
- HTOReamer
- GADRetractor
- HTXRongeur
- OURSacroiliac Joint Fixation
- HXXScrewdriver
- OCJSpinal Channeling Instrument, Vertebroplasty
- HXGTamp
- HWXTap, Bone
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain