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System, Facet Screw Spinal Device
FDA product code MRW · Class U · Unknown
2,408
Registered devices
105
Adverse events
4
Recalls
78
510(k) clearances
Devices with this code
CONCERO FACET SCREW SYSTEM — BIOMET SPINE LLCConcero™ Facet Screw System — BIOMET SPINE LLCPERPOS PLS SYSTEM, Dual Implant — INTERVENTIONAL SPINE, INCFacet Screw System — PRECISION SPINE, INC.UCSS® Screw Set — MEDTRONIC SOFAMOR DANEK, INC.3.8mm CS Facet Compression Device — INTERVENTIONAL SPINE, INCCONCERO FACET SCREW SYSTEM — BIOMET SPINE LLCConcero™ Facet Screw System — BIOMET SPINE LLCFacetFuse® — SPINEFRONTIER, INC.Disposable 5.5mm Drill Bit — SURGENTEC, LLCConcero™ Facet Screw System — BIOMET SPINE LLCOsteoMed — OSTEOMED LLCzLOCK 3.5mm — ZYGOFIX LTDArthrex® — ARTHREX, INC.CONCERO FACET SCREW SYSTEM — BIOMET SPINE LLCPolarfix™ Facet Screw System — CG MedTech Co.,Ltd.Faset — DIOMEDICAL CO.,LTD.FacetFuse® — SPINEFRONTIER, INC.ZAVATION — Zavation LLCFS3 Facet Screw Spinal System — Life Spine, Inc.FacetFuse® — SPINEFRONTIER, INC.FacetFuse® — SPINEFRONTIER, INC.CONCERO FACET SCREW SYSTEM — BIOMET SPINE LLCConcero™ Facet Screw System — BIOMET SPINE LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-27 | Medtronic Sofamor Danek USA, Inc | Product is impacted by a thread profile defect due to a manufacturing issue. |
| 2011-06-07 | Osteomed, Lp | Two of the Implant Driver Assembly tips were reported to break during surgery. |
| 2011-03-15 | Interventional Spine Inc | This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed wit |
| 2011-03-15 | Interventional Spine Inc | This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed wit |
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