510(k) K151131
K151131 is an FDA 510(k) premarket notification submitted by Ellipse Technologies, Incorporated for the device "PRECICE Intramedullary Limb Lengthening System". The FDA issued a decision of Substantially Equivalent on June 19, 2015. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Ellipse Technologies, Incorporated has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 2015
- Date Received
- April 28, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rod, Fixation, Intramedullary And Accessories
- Device Class
- Class II
- Regulation Number
- 888.3020
- Review Panel
- OR
- Submission Type