510(k) K120390
K120390 is an FDA 510(k) premarket notification submitted by Solana Surgical, LLC for the device "SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET". The FDA issued a decision of Substantially Equivalent on April 10, 2012. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Solana Surgical, LLC has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2012
- Date Received
- February 7, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type