QLR — Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices Class II
FDA product code QLR covers "Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices", a Class II medical device regulated under 21 CFR 888.4520. 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
- QLR
- Device Class
- Class II
- Regulation Number
- 888.4520
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253118 | Companion Spine France | Companion Spine DIAM Instrumentation | Dec 16, 2025 |