OJP · Orthopedic Computer Controlled Surgical System
Neurology · 21 CFR 882.4560 · Class 2
Overview
| Product Code | OJP |
|---|---|
| Device Name | Orthopedic Computer Controlled Surgical System |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K150741 | TSolution One w/ACG surgical System | THINK Surgical, Inc. | Oct 22, 2015 | SESE |
| K140585 | CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM | Curexo Technology Corporation | Aug 18, 2014 | SESE |
| K140038 | DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM | Curexo Technology Corporation | May 27, 2014 | SESE |
| K072629 | DIGIMATCH ROBODOC SURGICAL SYSTEM | Integrated Surgical Systems, Inc. | Aug 6, 2008 | SESE |
Top Applicants
- Curexo Technology Corporation — 2 clearances
- Integrated Surgical Systems, Inc. — 1 clearance
- THINK Surgical, Inc. — 1 clearance
