← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
PML — Bone Cement, Posterior Screw Augmentation
The device is intended to augment the fixation of screws in a posterior spinal system construct.
DEVICE CLASS
Class II
REGULATION
21 CFR 888.3027
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES
Recent clearances
K260286Spine Wave, Inc. · 510k2026-06-15
K252885Astura Medical · 510k2026-01-22
Related on SPEQ
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.