← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · UNCLASSIFIED

MRW — System, Facet Screw Spinal Device

DEVICE CLASS
Unclassified
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
13
510(K)/PMA CLEARANCES
510k: 13
0
RECALL ENTRIES

Recent clearances

K261209SurGenTec, LLC · 510k2026-06-11
K253676Providence Medical Technology, Inc. · 510k2026-05-14
K253432Vy Spine, LLC · 510k2026-03-19
K251714SurGenTec, LLC · 510k2026-01-16
K250679Sc Medica · 510k2025-12-04
K253190Providence Medical Technology, Inc. · 510k2025-11-20
K252153Sc Medica · 510k2025-10-16
K251885Providence Medical Technology, Inc. · 510k2025-07-10

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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