510(k) K113570
K113570 is an FDA 510(k) premarket notification submitted by Integra Burlington Ma, Inc. for the device "INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP". The FDA issued a decision of Substantially Equivalent on February 22, 2012. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2012
- Date Received
- December 2, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ultrasonic Surgical
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type