QHG — Defect Measurement Tool Class II
FDA product code QHG covers "Defect Measurement Tool", a Class II medical device regulated under 21 CFR 888.4510. Submissions are reviewed by the Orthopedic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QHG
- Device Class
- Class II
- Regulation Number
- 888.4510
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
Definition
Manual surgical instrument for appropriate patient select for orthopedic implant is a device used to measure an anatomical feature(s) to determine appropriate patient selection for an orthopedic implant. The characteristics of the instrument are defined by the specifications set for use of the orthopedic implant in terms of geometry, surgical technique, and use of the device.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201676 | intrinsic therapeutics | Barricaid Instrument Tray | July 16, 2020 |