510(k) K091159
K091159 is an FDA 510(k) premarket notification submitted by Synthes Spine for the device "SYNTHES ORACLE PLATE". The FDA issued a decision of Substantially Equivalent on July 10, 2009. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Synthes Spine has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2009
- Date Received
- April 21, 2009
- 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