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FDA PRODUCT CODE · CLASS II

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

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 888.4520
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

K253118Companion Spine France · 510k2025-12-16

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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