510(k) K101364
K101364 is an FDA 510(k) premarket notification submitted by Lanx, Inc. for the device "LANX FACET SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on August 16, 2010. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Lanx, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2010
- Date Received
- May 14, 2010
- 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