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Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices

FDA product code QLR · 1 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.4520
Review panel
OR
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-12-16 – 2025-12-16

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.

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