510(k) K152306
K152306 is an FDA 510(k) premarket notification submitted by Crossroads Extremity Systems, LLC for the device "MotoBand¿ CP Implant System". The FDA issued a decision of Substantially Equivalent on December 11, 2015. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Crossroads Extremity Systems, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2015
- Date Received
- August 14, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type