Intraoperative Orthopedic Strain Sensor
Device Code: 4694
Product Code(s):
QFP Definition: A Strain Sensor Device Is An Adjunct Tool Intended To Measure Strain On An Orthopedic Implant In The Intraoperative Setting Only. The Device Is Not Intended To Provide Diagnostic Information Or Influence Clinical Decision-making.
Device Classification Information
| Device Type ID | 4694 |
| Device Name | Intraoperative Orthopedic Strain Sensor |
| Physical State | The Device Is A Strain Gauge And Associated Reader And Display Instruments. |
| Technical Method | The Sensor Measures Strain On The Implant Via A Strain Gauge And Provides The Output Reading On A Display. |
| Target Area | Bone |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3090 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QFP |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 4694 |
| Device | Intraoperative Orthopedic Strain Sensor |
| Product Code | QFP |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 888.3090 [🔎] |
TPLC Last Update: 2019-04-02 20:54:00