510(k) K151360
K151360 is an FDA 510(k) premarket notification submitted by Inion OY for the device "Inion Spinal Graft Containment System". The FDA issued a decision of SESU on October 6, 2015. The device falls under product code OJB (Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate), a Class II device regulated under 21 CFR 888.3060. Inion OY has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- October 6, 2015
- Date Received
- May 20, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type
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.