Neurostructures, Inc.
Colorado Springs, CO, US
Neurostructures, Inc. appears in FDA device records in Colorado Springs, CO. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Neurostructures, Inc. between 2012 and 2020. The busiest year on record is 2018, with 6. The most recent is 2020, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 6 |
| 2019 | 1 |
| 2020 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K202190 | Oculus-SA Lumbar Cage System | OVD | Substantially Equivalent | |
| K200115 | Cavetto-SA Cervical Cage System | OVE | Substantially Equivalent | |
| K201769 | Cavetto [MAX] Cervical Cage System | ODP | Substantially Equivalent | |
| K200927 | Transept Cervical Plate System | KWQ | Substantially Equivalent | |
| K192248 | Cortina™ [MAX] Lumbar Cage System | MAX | Substantially Equivalent | |
| K182195 | Arco™-SA Lumbar Cage System | OVD | Substantially Equivalent | |
| K181590 | Neurostructures Cavetto® [MAX] Cervical Cage System | ODP | Substantially Equivalent | |
| K173082 | Arco™-SA Lumbar Cage System | OVD | Substantially Equivalent | |
| K180431 | Cortina [MAX] Lumbar Cage System | MAX | Substantially Equivalent | |
| K172320 | Neurostructures Cavetto® Cervical Cage System | ODP | Substantially Equivalent | |
| K173077 | Cavetto-SA Cervical Cage System | OVE | Substantially Equivalent | |
| K171914 | Cortina™ Lumbar Cage System | MAX | Substantially Equivalent | |
| K171112 | Trifore(tm) Cervical Plating System | KWQ | Substantially Equivalent | |
| K153097 | Belvedere™ Lateral Plating System | KWQ | Substantially Equivalent | |
| K143230 | Palladian Lumbar Pedicle Screw System | NKB | Substantially Equivalent | |
| K142060 | TRANSOM ANTERIOR CERVICAL PLATE | KWQ | Substantially Equivalent | |
| K131374 | TEMPUS(TM) CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K121551 | RESOLUTE FACET SCREW SYSTEM | MRW | Substantially Equivalent | |
| K120515 | TEMPUS CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWQAppliance, Fixation, Spinal Intervertebral Body
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- MRWSystem, Facet Screw Spinal Device
- NKBThoracolumbosacral Pedicle Screw System
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
