K151360 is an FDA 510(k) clearance for the Inion Spinal Graft Containment System. This device is classified as a Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate (Class II - Special Controls, product code OJB).
Submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on October 6, 2015, 139 days after receiving the submission on May 20, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060. Maintain Position Of Bone Graft In Spinal Fusion Procedures. Intended For Use In Spinal Fusion Procedures As A Means To Maintain The Relative Position Of Weak Bony Tissue Such As Allografts Or Autografts, In Conjunction With Traditional Rigid Fixation..
| 510(k) Number | K151360 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | May 20, 2015 |
| Decision Date | October 06, 2015 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OJB - Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |
| Definition | Maintain Position Of Bone Graft In Spinal Fusion Procedures. Intended For Use In Spinal Fusion Procedures As A Means To Maintain The Relative Position Of Weak Bony Tissue Such As Allografts Or Autografts, In Conjunction With Traditional Rigid Fixation. |