Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices are Class 2 orthopedic surgical instruments intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process spacer devices used in non-fusion spinal procedures. They require 510(k) clearance and are regulated under 21 CFR 888.4520 within the Orthopedic medical specialty. The product code is QLR. The devices are not implants and are not flagged as life-sustaining.
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Basic Information
- Product Code
- QLR
- Device Class
- FDA class 2
- Regulation Number
- 888.4520
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253118 | Companion Spine DIAM Instrumentation | Dec 16, 2025 | Substantially Equivalent | Companion Spine France |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.