Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Manual Instruments Designed For Use With Total Disc Replacement Devices

FDA product code QLQ · 9 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.4515
Review panel
OR
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2021-08-20 – 2026-08-14

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

↑