510(k) K122890
K122890 is an FDA 510(k) premarket notification submitted by Inion OY for the device "INION CPS ORBITAL PLATES". The FDA issued a decision of Substantially Equivalent on January 29, 2013. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Inion OY has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2013
- Date Received
- September 20, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type