Medical Device Manufacturer · US , Marquette , MI

Pioneer Surgical Technology, Inc. - FDA 510(k) Cleared Devices

26 submissions · 26 cleared · Since 2010

Recent clearances: Resolve Anterior Cervical Plate System, CODA™ Anterior Cervical Plate System, CervAlign® Anterior Cervical Plate System

26

Total

26

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pioneer Surgical Technology, Inc. Orthopedic ✕

26 devices

1-12 of 26

Cleared Jul 11, 2025

Resolve Anterior Cervical Plate System

Orthopedic · 64d

Cleared Nov 18, 2022

CODA™ Anterior Cervical Plate System

Orthopedic · 92d

Cleared Jun 23, 2021

CervAlign® Anterior Cervical Plate System

Orthopedic · 48d

Cleared Nov 26, 2019

Streamline MIS Spinal Fixation System

Orthopedic · 84d

Cleared Apr 10, 2014

STREAMLINE TL SPINAL FIXATION SYSTEM

Orthopedic · 22d

Cleared Mar 27, 2014

CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC

Orthopedic · 135d

Cleared Feb 10, 2014

Orthopedic · 76d

Cleared Feb 07, 2014

NB3D BONE VOID FILLER

Orthopedic · 220d

Cleared Jan 27, 2014

TRITIUM STERNAL CABLE PLATE SYSTEM

Orthopedic · 46d

Cleared Dec 24, 2013

PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE

Orthopedic · 195d

Cleared Jun 27, 2013

STREAMLINE TL SPINAL SYSTEM

Orthopedic · 69d

Cleared Jun 05, 2013

PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM

Orthopedic · 105d