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PIONEER SURGICAL TECHNOLOGY, INC.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
76
Inspections
11
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2076-2014Class IITritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical CabJune 11, 2014
Z-2616-2014Class IIStreamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS SJune 14, 2013
Z-2573-2014Class IISTREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLYSeptember 10, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K251436Resolve Anterior Cervical Plate SystemJuly 11, 2025
K222493CODA™ Anterior Cervical Plate SystemNovember 18, 2022
K211408CervAlign® Anterior Cervical Plate SystemJune 23, 2021
K192396Streamline MIS Spinal Fixation SystemNovember 26, 2019
K140696STREAMLINE TL SPINAL FIXATION SYSTEMApril 10, 2014
K133455CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTICMarch 27, 2014
K133623C-PLUSFebruary 10, 2014
K132050NB3D BONE VOID FILLERFebruary 7, 2014
K133785TRITIUM STERNAL CABLE PLATE SYSTEMJanuary 27, 2014
K131724PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICEDecember 24, 2013
K131100STREAMLINE TL SPINAL SYSTEMJune 27, 2013
K130427PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEMJune 5, 2013
K130286STREAMLINE MIS SPINAL FIXATION SYSTEMApril 1, 2013
K121725PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEMNovember 7, 2012
K122293PIONEER STERNAL CABLE PLATE SYSTEMOctober 12, 2012
K120016PIONEER STERNAL ASSIST IMPLANT SYSTEMJuly 26, 2012
K120724PIONEER LATERAL PLATE SYSTEMMay 7, 2012
K112757PIONEER POSTERIOR CERVICO THORACIC SYSTEMMarch 12, 2012
K113218PIONEER RELEASE LAMINOPLASTY PLATING SYSTEMJanuary 26, 2012
K111944NB3D BONE VOID FILLERNovember 22, 2011