QLR
- Product code
- QLR
- Device name
- Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.4520
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
FDA classification definition
The devices are intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process spacer devices for non-fusion use.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253118 | 2025-12-16 | Companion Spine France | Companion Spine DIAM Instrumentation |
Official FDA classification page: QLR
Classification and pathway per current FDA publications. Data from openFDA (CC0).