OJP · Class II · 21 CFR 882.4560

FDA Product Code OJP: Orthopedic Computer Controlled Surgical System

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).

Leading manufacturers include Curexo Technology Corporation, Integrated Surgical Systems, Inc. and THINK Surgical, Inc..

4
Total
4
Cleared
210d
Avg days
2008
Since

FDA 510(k) Cleared Orthopedic Computer Controlled Surgical System Devices (Product Code OJP)

4 devices
1–4 of 4
Cleared Oct 22, 2015
TSolution One w/ACG surgical System
K150741
THINK Surgical, Inc.
Orthopedic · 213d
Cleared Aug 18, 2014
CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM
K140585
Curexo Technology Corporation
Orthopedic · 164d
Cleared May 27, 2014
DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM
K140038
Curexo Technology Corporation
Orthopedic · 140d
Cleared Aug 06, 2008
DIGIMATCH ROBODOC SURGICAL SYSTEM
K072629
Integrated Surgical Systems, Inc.
Orthopedic · 324d

About Product Code OJP - Regulatory Context