K230927 is an FDA 510(k) clearance for the OptiMesh Multiplanar Expandable Interbody Fusion System. This device is classified as a Intervertebral Body Graft Containment Device (Class II - Special Controls, product code OQB).
Submitted by Spineology, Inc. (Saint Paul, US). The FDA issued a Cleared decision on November 1, 2023, 212 days after receiving the submission on April 3, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3085. An Intervertebral Body Graft Containment Device Is A Non-rigid, Implanted Spinal Device That Is Designed To Contain Bone Graft Within Its Internal Cavity. The Device Is Inserted Into The Intervertebral Body Space Of The Spine And Is Intended As An Adjunct To Intervertebral Body Fusion..
| 510(k) Number | K230927 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2023 |
| Decision Date | November 01, 2023 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OQB — Intervertebral Body Graft Containment Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3085 |
| Definition | An Intervertebral Body Graft Containment Device Is A Non-rigid, Implanted Spinal Device That Is Designed To Contain Bone Graft Within Its Internal Cavity. The Device Is Inserted Into The Intervertebral Body Space Of The Spine And Is Intended As An Adjunct To Intervertebral Body Fusion. |