| Device |
orthopedic stereotaxic instrument |
| Regulation Description |
Stereotaxic instrument. |
| Definition |
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW. |
| Physical State |
Device consists of Camera, computer, various shaped tracking arrays, computer interface for commmunication between user and device. |
| Technical Method |
User loads Computer software pre-Op to plan surgery procedure, then registers the patient anatomy during surgery to allow software to track patient anatomy, implants, and surgical tools in real time/space. |
| Target Area |
Orthopedic joints and spinal procedures where tracking of instrumentation is desired. |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Orthopedic |
|---|
| Product Code | OLO |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Restorative, Repair and Trauma Devices
(DHT6C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.4560
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
