510(k) K131512
K131512 is an FDA 510(k) premarket notification submitted by Shanghai Sanyou Medical Co, Ltd. for the device "KATIA SYSTEM". The FDA issued a decision of Substantially Equivalent on August 7, 2013. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Shanghai Sanyou Medical Co, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2013
- Date Received
- May 28, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Spinal Intervertebral Body
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type