QHG · Defect Measurement Tool
Orthopedic · 21 CFR 888.4510 · Class 2
Overview
| Product Code | QHG |
|---|---|
| Device Name | Defect Measurement Tool |
| Regulation | 21 CFR 888.4510 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
Identification
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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201676 | Barricaid Instrument Tray | Intrinsic Therapeutics, Inc. | Jul 16, 2020 | SESE |
Top Applicants
- Intrinsic Therapeutics, Inc. — 1 clearance
