510(k) K092568
K092568 is an FDA 510(k) premarket notification submitted by Amendia, Inc. for the device "SPARTAN S3 FACET SYSTEM". The FDA issued a decision of Substantially Equivalent on November 17, 2009. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Amendia, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 2009
- Date Received
- August 20, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Facet Screw Spinal Device
- Device Class
- Class U
- Regulation Number
- Review Panel
- OR
- Submission Type