510(k) K110283
K110283 is an FDA 510(k) premarket notification submitted by Medyssey Co, Ltd. for the device "ZENIUS SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on May 19, 2011. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Medyssey Co, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 2011
- Date Received
- February 1, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Spinal Pedicle Fixation
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type