QLR

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class II (moderate risk)

Regulation

21 CFR 888.4520

Medical specialty

Orthopedic

FDA 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.

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