27 orthopedic, spine devices receive FDA 510(k) clearance in April

Spinal Tech

The FDA cleared 27 orthopedic and spine related devices last month.

 

Zimmer Biomet Ceramic Heads from Zimmer Biomet.

Syntec Femoral Nail System from Syntec Scientific.

InterSpace Knee Extra Large Size, Interspace Knee ATS from Tecres.

CREO Stabilization System, Navigation Instruments, ExcelsiusGPS from Globus Medical.

Comprehensive Nano Stemless Shoulder from Biomet.

Assure Anterior Cervical Plate System from Globus Medical.

CyclaPlex Correction System from Cycla Orthopedics.

FlareHawk Interbody Fusion System from Integrity Implants.

Pyramesh Implant System from Medtronic Sofamor Danek.

SambaScrew 3D SI Fusion System from Orthofix.

Vantage Total Ankle Flat Cut Talar from Exactech.

Arthrex 2.5 mm Tenodesis Screw from Arthrex.

Vitality Spinal Fixation System from Zimmer Biomet Spine.

OIC External Fixation System from Orthopaedic Implant Company.

NanoBone Sbx Putty from Artoss.

iFuse Implant System from SI-BONE.

Karma Fixation System from Spinal Elements.

AltiVate Reverse Humeral Stem, 48 mm from Encore Medical.

Zavation Spinal System from Zavation Medical Products.

Atlas Plating System from MiRus.

Monster Screw System from Paragon.

Crossway Spinal Access System from Globus Medical.

ExcelsiusGPS from Globus Medical.

SeaSpine Shoreline ACS Anterior Cervical Standalone System from SeaSpine Orthopedics.

MIS Bunion Plating System from CrossRoads Extremity Systems.

Arthrex SwiveLock Anchors from Arthrex.

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