510(k) K051821
K051821 is an FDA 510(k) premarket notification submitted by Inion , Ltd. for the device "INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on November 25, 2005. 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 , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 2005
- Date Received
- July 5, 2005
- 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.