FDA product code QLQ

Manual Instruments Designed For Use With Total Disc Replacement Devices

Orthopedic·Class 2·21 CFR 888.4515
US regulatory classifications
US Product Code (FDA)
QLQ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 888.4515
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Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.

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About this record

Manual Instruments Designed For Use With Total Disc Replacement Devices is a medical device type in the Orthopedic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.