FDA Device Intelligence
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Bone Cement, Posterior Screw Augmentation

FDA product code PML · Class 2 · Orthopedic

2,011
Registered devices
310
Adverse events
2
Recalls
19
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2023-11-28Icotec Agicotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved
2023-11-28Icotec Agicotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.