Stryker Spine

FDA Regulatory Profile

Summary

Total Recalls
29 (1 Class I)
510(k) Clearances
73
Inspections
12
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1490-2025Class IIMonterey AL Implant Inserter; 18/20mm; Catalog 48019130.February 28, 2025
Z-1489-2025Class IIMonterey AL Implant Inserter; 14/16mm; Catalog 48019120.February 28, 2025
Z-1491-2025Class IIMonterey AL Implant Inserter; 22mm; Catalog 48019140.February 28, 2025
Z-1488-2025Class IIMonterey AL Implant Inserter; 10/12mm; Catalog 48019100.February 28, 2025
Z-3210-2024Class IIAVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anteriAugust 23, 2024
Z-0610-2024Class IILITe Decompression Snake Arm, REF 48080230November 1, 2023
Z-2101-2021Class IICortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979May 18, 2021
Z-2100-2021Class IICortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962May 18, 2021
Z-1437-2021Class IITritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL InserMarch 11, 2021
Z-0092-2019Class IIAVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK SpacerAugust 13, 2018
Z-0828-2016Class IIStryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker SDecember 18, 2015
Z-0852-2016Class IIAccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hDecember 16, 2015
Z-0270-2016Class IIStryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional suppoSeptember 25, 2015
Z-0222-2016Class IIStryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. ReferenSeptember 8, 2015
Z-0803-2015Class IISpecialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. UseOctober 6, 2014
Z-2626-2014Class IIStryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand.July 7, 2014
Z-2627-2014Class IISpecialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria producJuly 7, 2014
Z-1086-2014Class IISpecialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the NDecember 18, 2013
Z-0375-2014Class IIStryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench ManufSeptember 24, 2013
Z-1976-2013Class IStryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows foMay 30, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal SNovember 7, 2024
K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft SubAugust 29, 2024
K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, June 8, 2023
K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, TrFebruary 14, 2023
K203205Navigated Spine InstrumentsMarch 23, 2021
K200666Stryker Xia 3 Power AdaptorApril 23, 2020
K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar CJuly 25, 2019
K183071VLIFT-s Vertebral Body Replacement SystemJanuary 10, 2019
K181014Tritanium PL CageJuly 18, 2018
K171496Tritanium C Anterior Cervical CageSeptember 6, 2017
K161407Ascential IBD PEEKc SpacerJuly 15, 2016
K152532AERO -C Cervical Cage SystemDecember 18, 2015
K133188MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, ANDDecember 17, 2013
K132968UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)November 18, 2013
K122845ES2 SPINAL SYSTEM MODEL 48280XXXXDecember 7, 2012
K122637LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999November 1, 2012
K120869ANCHOR-L LUMBAR CAGEOctober 25, 2012
K113666XIA 3 SPINAL SYSTEMAugust 28, 2012
K120486AVS AS PEEK SPACERAugust 20, 2012
K113802ESCALATE LAMINOPLASTY SYSTEMApril 16, 2012