SpineFrontier, Inc.

FDA Regulatory Profile

Summary

Total Recalls
33
510(k) Clearances
24
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1973-2019Class IIA-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 andJune 13, 2019
Z-1479-2015Class IISpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023March 5, 2015
Z-0977-2015Class IIlnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164December 19, 2014
Z-0553-2014Class IIPedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse ScrewNovember 20, 2013
Z-0575-2014Class IIIndus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical PNovember 20, 2013
Z-0555-2014Class IIPedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse ScrewNovember 20, 2013
Z-0574-2014Class IIIndus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue AnterioNovember 20, 2013
Z-0554-2014Class IIPedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse ScrNovember 20, 2013
Z-0576-2014Class IIIndus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue AnteriorNovember 20, 2013
Z-0573-2014Class IIIndus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior November 20, 2013
Z-0544-2014Class IIPedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be uOctober 18, 2013
Z-0778-2014Class IIArena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 September 24, 2013
Z-0776-2014Class IIArena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint oSeptember 24, 2013
Z-0777-2014Class IIArena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 1September 24, 2013
Z-0624-2014Class IIPedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.September 11, 2013
Z-0274-2014Class IIS-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectaAugust 28, 2013
Z-1933-2013Class IIIndus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case,June 21, 2013
Z-1665-2013Class IIS-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to adMay 24, 2013
Z-1664-2013Class IIBASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all inMay 17, 2013
Z-1927-2013Class IIInvue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue AMay 10, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K193106SpineFrontier Lumbar Interbody Fusion Device SystemJune 19, 2020
K172484A-CIFT SoloFuseMay 8, 2018
K151198A-CIFT SoloFuseJuly 17, 2015
K142504SpineFrontier Lumbar Interbody Fusion Device SystemMay 13, 2015
K150017SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemApril 24, 2015
K143377PedFuse Pedicle Screw SystemFebruary 12, 2015
K141333ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICENovember 25, 2014
K142026SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICEOctober 20, 2014
K141337ARENA-CSeptember 8, 2014
K133153SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEMMay 14, 2014
K131880SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEMJanuary 3, 2014
K132740SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEMNovember 26, 2013
K123164SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEMFebruary 15, 2013
K121060SPINE FRONTIER INDUS ACP SYSTEMJuly 3, 2012
K113518ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEMFebruary 16, 2012
K111553SPINEFRONTIER LUMBAR IBF SYSTEMSeptember 28, 2011
K102020VEGA SPAN SPINOUS PROCESS PLATE SYSTEMSeptember 1, 2010
K092815S-LIF INTERVERTEBRAL BODY FUSION DEVICEJune 30, 2010
K093776INDUS ANTERIOR CERVICAL PLATE SYSTEMMarch 26, 2010
K092420KRD1 PEDICLE SCREW SYSTEMNovember 19, 2009