OJPClass II
Orthopedic Computer Controlled Surgical System
Neurology · 21 CFR 882.4560
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).
MDR events3All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances4All time
Recent MDR events
3 adverse event reports on file
Event type breakdown
Unspecified1
Injury1
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
4 clearances for this product code
- THINK Surgical, Inc.Oct 22, 2015
K150741 · TSolution One w/ACG surgical System
- Curexo Technology CorporationAug 18, 2014
K140585 · CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM
- Curexo Technology CorporationMay 27, 2014
K140038 · DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM
- Integrated Surgical Systems, Inc.Aug 6, 2008
K072629 · DIGIMATCH ROBODOC SURGICAL SYSTEM