29 spine, orthopedic devices receive FDA 510(k) clearance in August

Spinal Tech

The FDA granted 29 orthopedic- and spine-related device clearances in August.

Double Medical Universal Spine System from Double Medical Technology.

 

Alians Elbow Locking Plating System from NewClip Technics.

 

Hammertoe Correction System from Life Spine.

 

Vertu & Vertu Ti-Bond and Crystal & Crystal Ti-Bond Cervical Interbody System from Spinal Elements.

 

Salto XT, Salto Talaris from Tornier SAS.

 

Exactech Novation Element Press-fit Femoral Stem from Exactech.

 

JointPoint from JointPoint.

 

Independence MIS Spacers from Globus Medical.

 

XYcor Expandable Spinal Spacer System from Alphatec Spine.

 

Virtu Lumbar Spacer System from Met 1 Technologies.

 

Zion Anterior Cervical Fixation System from Astura Medical.

 

SpineView X-Pac Expandable Lumbar Cage System from SpineView.

 

Kyphon HV-R Bone Cement from Medtronic.

 

AFX Femoral Implant With Inserter from Cayenne Medical.

 

Tarsa-Link Stand-Alone Wedge Fixation System from Life Spine.

 

Arthrex VaultLock Glenoid from Arthrex.

 

Integra Titan Reverse Shoulder System from Integra LifeSciences.

 

Rialto SI Fusion System, Medtronic Reusable Instruments for Use with the IPC Powerease System and Medtronic Navigated Manual Reusable Instruments for use with StealthStation and IPC Powerease Systems from Medtronic Sofamor Danek.

 

NuVasive Lumbar Interbody Implants from NuVasive.

 

Response BandLoc Spinal Fixation from OrthoPediatrics.

 

Distal Radius Plating System from Miami Device Solutions.

 

Mont Blanc and Mont Blanc MIS Spinal Systems from SpineWay.

 

Valeo II Interbody Fusion Device System from Amedica.

 

Streamline OCT Occipito-Cervico-Thoracic System from Pioneer Surgical Technology.

 

PathLoc-L MIS Spinal System from L&K Biomed.

 

FacetBRIDGE System from LDR Spine.

 

ARIX Foot System from JEIL Medical.

 

Genesys Spine TiLock Cortical Spinal System from Genesys Spine.

 

ANAX 5.5 Spinal System from U&I Corporation.

 

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