Product code QLR

Device name

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

Medical specialty

Orthopedic

Device class

2

Regulation number

888.4520

Review panel

OR

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset