510(k) K140585
K140585 is an FDA 510(k) premarket notification submitted by Curexo Technology Corporation for the device "CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on August 18, 2014. The device falls under product code OJP (Orthopedic Computer Controlled Surgical System), a Class II device regulated under 21 CFR 882.4560. Curexo Technology Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2014
- Date Received
- March 7, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthopedic Computer Controlled Surgical System
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- OR
- Submission Type
Pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision. Alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).