QFPClass II
Intraoperative Orthopedic Strain Sensor
21 CFR 888.3090 / Orthopedic
QFP is the FDA product code for Intraoperative Orthopedic Strain Sensor, a class II device type, regulated under 21 CFR 888.3090. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QFP
- Device name
- Intraoperative Orthopedic Strain Sensor
- FDA 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.
- Regulation
- 21 CFR 888.3090
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QFP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2019 | 1 |
Applicants with the most clearances
Product code QFP| Applicant | Clearances |
|---|---|
| Intellirod Spine, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code QFP.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.