Medical Device Manufacturer · US , Marquette , MI

Pioneer Surgical Technology, Inc.

26 submissions · 26 cleared · Since 2010
26
Total
26
Cleared
0
Denied

Pioneer Surgical Technology, Inc. — FDA 510(k) Submissions

Pioneer Surgical Technology, Inc. has submitted 26 FDA 510(k) premarket notifications since 2010, of which 26 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Thoracolumbosacral Pedicle Screw System, Appliance, Fixation, Spinal Intervertebral Body, Appliance, Fixation, Spinal Interlaminal, Filler, Bone Void, Calcium Compound, Intervertebral Fusion Device With Bone Graft, Lumbar . Use the specialty filter in the sidebar to narrow results.

26 devices
1–25 of 26
Resolve Anterior Cervical Plate System
K251436 · KWQ Appliance, Fixation,... · Orthopedic
Jul 2025 64d
CODA? Anterior Cervical Plate System
K222493 · KWQ Appliance, Fixation,... · Orthopedic
Nov 2022 92d
CervAlign? Anterior Cervical Plate System
K211408 · KWQ Appliance, Fixation,... · Orthopedic
Jun 2021 48d
Streamline MIS Spinal Fixation System
K192396 · NKB Thoracolumbosacral... · Orthopedic
Nov 2019 84d
STREAMLINE TL SPINAL FIXATION SYSTEM
K140696 · NKB Thoracolumbosacral... · Orthopedic
Apr 2014 22d
CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
K133455 · MAX Intervertebral Fusion... · Orthopedic
Mar 2014 135d
C-PLUS
K133623 · ODP Intervertebral Fusion... · Orthopedic
Feb 2014 76d
NB3D BONE VOID FILLER
K132050 · MQV Filler, Bone Void,... · Orthopedic
Feb 2014 220d
TRITIUM STERNAL CABLE PLATE SYSTEM
K133785 · JDQ Cerclage, Fixation · Orthopedic
Jan 2014 46d
PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE
K131724 · MQP Spinal Vertebral Body... · Orthopedic
Dec 2013 195d
STREAMLINE TL SPINAL SYSTEM
K131100 · NKB Thoracolumbosacral... · Orthopedic
Jun 2013 69d
PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM
K130427 · KWQ Appliance, Fixation,... · Orthopedic
Jun 2013 105d
STREAMLINE MIS SPINAL FIXATION SYSTEM
K130286 · NKB Thoracolumbosacral... · Orthopedic
Apr 2013 55d
PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
K121725 · KWP Appliance, Fixation,... · Orthopedic
Nov 2012 148d
PIONEER STERNAL CABLE PLATE SYSTEM
K122293 · HRS Plate, Fixation, Bone · Orthopedic
Oct 2012 73d
PIONEER STERNAL ASSIST IMPLANT SYSTEM
K120016 · HRS Plate, Fixation, Bone · Orthopedic
Jul 2012 205d
PIONEER LATERAL PLATE SYSTEM
K120724 · KWQ Appliance, Fixation,... · Orthopedic
May 2012 59d
PIONEER POSTERIOR CERVICO THORACIC SYSTEM
K112757 · KWP Appliance, Fixation,... · Orthopedic
Mar 2012 172d
PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM
K113218 · NQW Orthosis, Spine, Plate,... · Orthopedic
Jan 2012 86d
NB3D BONE VOID FILLER
K111944 · MQV Filler, Bone Void,... · Orthopedic
Nov 2011 137d
PIONEER CROSSFUSE II IBF/VBR SYSTEM
K112496 · MAX Intervertebral Fusion... · Orthopedic
Sep 2011 30d
PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES
K111528 · KWQ Appliance, Fixation,... · Orthopedic
Aug 2011 83d
STREAMLINE TL SPINAL SYSTEM
K111502 · NKB Thoracolumbosacral... · Orthopedic
Aug 2011 84d
STREAMLINE TL SPINAL SYSTEM
K110692 · NKB Thoracolumbosacral... · Orthopedic
May 2011 62d
PIONEER SPINAL PROCESS FUSION PLATE
K110367 · KWP Appliance, Fixation,... · Orthopedic
Mar 2011 43d
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