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Bone Cement, Posterior Screw Augmentation
FDA product code PML · Class 2 · Orthopedic
2,019
Registered devices
317
Adverse events
2
Recalls
19
510(k) clearances
Devices with this code
CarboClear Hybrid Pedicle Screw System — CARBOFIX ORTHOPEDICS LTDReLine — Nuvasive, Inc.VIPER — Medos International SàrlReLine — Nuvasive, Inc.ReLine — Nuvasive, Inc.VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 6.5 x 40 mm — icotec AGCarboClear Pedicle Screw Systems — CARBOFIX ORTHOPEDICS LTDReLine — Nuvasive, Inc.EXPEDIUM VERSE — Medos International SàrlReLine — Nuvasive, Inc.VADER Pedicle System, Template for HT S-rods — icotec AGReLine — Nuvasive, Inc.ReLine — Nuvasive, Inc.Reform Ti Modular — PRECISION SPINE, INC.ReLine — Nuvasive, Inc.ReLine — Nuvasive, Inc.ReLine — Nuvasive, Inc.CarboClear Hybrid Pedicle Screw System — CARBOFIX ORTHOPEDICS LTDReLine — Nuvasive, Inc.ReLine — Nuvasive, Inc.ReLine — Nuvasive, Inc.ReLine — Nuvasive, Inc.ReLine — Nuvasive, Inc.CarboClear Hybrid Pedicle Screw System — CARBOFIX ORTHOPEDICS LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-28 | Icotec Ag | icotec 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 |
| 2023-11-28 | Icotec Ag | icotec 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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