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FDA PRODUCT CODE · CLASS II

QLQ — Manual Instruments Designed For Use With Total Disc Replacement Devices

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

DEVICE CLASS
Class II
REGULATION
21 CFR 888.4515
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K253392Synergy Spine Solutions, Inc. · 510k2026-03-27
K250554Centinel Spine, LLC · 510k2025-04-25
K242869Centinel Spine, LLC · 510k2024-12-17

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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