FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System— 510(k) K172269
Substantially EquivalentGlobus Medical, Inc.
FDA 510(k) clearance K172269 for FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System, Substantially Equivalent on 2018-03-27. Applicant: Globus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Globus Medical, Inc.
- Product code
- Code PML
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Audubon, PA, US
Recent devices under product code PML
view all- K260286 — Dynamo Spinal Cement; Salvo® Spine System
- K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
- K241034 — Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
- K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement +1 more
- K230774 — PERLA® TL System; TEKTONA® HV US Bone Cement
More clearances from Globus Medical, Inc.
view all- K254043 — TRIVANCE Hip Stem
- K262251 — ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)
- K253739 — SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System
- K253401 — SCRIPT Implant System
- K261043 — AUTOBAHN Nailing System
Adverse events under product code PML
product code PML- Death
- 8
- Total
- 8
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.