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Data / Medical devices / United States / Pioneer Surgical Technology, Inc.

Pioneer Surgical Technology, Inc.: FDA-registered device maker in Marquette, MI, United States, 15 510(k) clearances

Pioneer Surgical Technology, Inc. is registered with the FDA (registration 1833824) in Marquette, MI, United States. It lists 44 device types. The FDA files 15 510(k) clearances under its listings, the newest dated July 16, 2026. 19 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Pioneer Surgical Technology, Inc.
FDA registration number
1833824
FEI number
1000115331
Address
375 River Park Circle, Marquette, MI, United States, 49855
Owner or operator
Pioneer Surgical Technology, Inc. (10084252)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
January 31, 2022
Registered through
2027
Brand names listed
CODA™ Anterior Cervical Plate System, CRIMP POSITIONING PINS, Cable-Ready Cable Grip System: Cable-Ready Bone Plate System, Cable-Ready® Cable Grip System, Cable-Ready® Cable Grip System Instruments, Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System, Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables, Cable-Ready®* Cable Grip System: Greater Trochanteric Reattachment Device (GTR) and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Fixation, Spinal Intervertebral BodyLYQ1Contract manufacturer, Manufactureraccessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal InterlaminalKWP2Contract manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Contract manufacturer, Manufactureraccessdata.fda.gov
Applier, CerclageHXN1Manufactureraccessdata.fda.gov
AwlHWJ1Contract manufacturer, Manufactureraccessdata.fda.gov
BenderHXW1Contract manufacturer, Manufactureraccessdata.fda.gov
Bit, DrillHTW1Contract manufacturer, Manufactureraccessdata.fda.gov
CaliperKTZ1Contract manufactureraccessdata.fda.gov
Cerclage, FixationJDQ2Contract manufacturer, Manufactureraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Contract manufactureraccessdata.fda.gov
Crimper, PinHXQ1Manufactureraccessdata.fda.gov
Cutter, SurgicalFZT1Contract manufactureraccessdata.fda.gov
Cutter, WireHXZ1Manufactureraccessdata.fda.gov
Driver, ProsthesisHWR1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Contract manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Contract manufacturer, Manufactureraccessdata.fda.gov
ImpactorHWA1Manufactureraccessdata.fda.gov
Instrument, CompressionHWN1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Contract manufacturer, Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Contract manufactureraccessdata.fda.gov
PasserHWQ1Manufactureraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufacturer, Manufactureraccessdata.fda.gov
Pliers, SurgicalHTC1Contract manufactureraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Contract manufactureraccessdata.fda.gov
RetractorGAD1Contract manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufacturer, Manufactureraccessdata.fda.gov
ScrewdriverHXX1Contract manufacturer, Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGAQ2Contract manufactureraccessdata.fda.gov
TampHXG1Contract manufactureraccessdata.fda.gov
Tap, BoneHWX1Contract manufacturer, Manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Contract manufactureraccessdata.fda.gov
TemplateHWT1Contract manufacturer, Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Contract manufactureraccessdata.fda.gov
Tray, SurgicalLRP1Contract manufacturer, Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Contract manufacturer, Manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Manufactureraccessdata.fda.gov
WrenchHXC1Contract manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 16, 2026K261271Cable-Ready® Cable Grip SystemJDQSubstantially EquivalentPioneer Surgical Technology, Inc.accessdata.fda.gov
June 20, 2023K230993CODA™ Anterior Cervical Plate SystemKWQSubstantially EquivalentPioneer Surgical Technology, Inc D.B.A Resolve Surgical Techaccessdata.fda.gov
November 18, 2022K222493CODA™ Anterior Cervical Plate SystemKWQSubstantially EquivalentPioneer Surgical Technology, Inc.accessdata.fda.gov
April 28, 2022K220244DVR® Crosslock Wrist Spanning Plate (131849181)HRSSubstantially EquivalentPioneer Surgical Technology, Inc D.B.A Resolve Surgical Techaccessdata.fda.gov
October 28, 2020K201497EVOS Cabling SystemJDQSubstantially EquivalentPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)accessdata.fda.gov
January 28, 2016K151716Cable-Ready Cable Grip System: Cable-Ready Bone Plate SystemHRSSubstantially EquivalentZimmer, Inc.accessdata.fda.gov
January 15, 2016K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemJDQSubstantially EquivalentZimmer, Inc.accessdata.fda.gov
December 30, 2015K151907Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage CablesKTTSubstantially EquivalentZimmer, Inc.accessdata.fda.gov
February 8, 2001K003496CANNULATED SCREW SYSTEMHTNSubstantially EquivalentPioneer Surgical Technologyaccessdata.fda.gov
October 6, 2000K002110SPL CRIMP SYSTEMJDQSubstantially EquivalentPioneer Surgical Technologyaccessdata.fda.gov
August 31, 2000K001709TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067JDQSubstantially EquivalentPioneer Surgical Technologyaccessdata.fda.gov
May 5, 2000K000734PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601KTTSubstantially EquivalentPioneer Surgical Technologyaccessdata.fda.gov
October 27, 1999K992617HEX BUTTONHTNSubstantially EquivalentPioneer Surgical Technologyaccessdata.fda.gov
October 27, 1999K992616SDB CERCLAGE SYSTEMJDQSubstantially EquivalentPioneer Surgical Technologyaccessdata.fda.gov
April 19, 1994K941213SONGER CABLE SYSTEMJDQSubstantially Equivalent for Some IndicationsPioneer Surgical Technologyaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
January 15, 202187251Class IIOngoingCervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defLocking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revisionaccessdata.fda.gov
September 24, 202086595Class IIOngoingStreamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device.System does not include a drill guide.accessdata.fda.gov
September 24, 202086559Class IITerminatedStreamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWIThe Streamline Navigation System taps have experienced binding with other devices.accessdata.fda.gov
September 11, 202086591Class IITerminatedStreamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCRThe Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.accessdata.fda.gov
September 16, 201675242Class IITerminatedRTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the SRTI Surgical Inc. (RTI) is conducting a voluntary recall on two specific lots of the Streamline OCT Straight Rod, CoCr. 3.2mm (D) x 240mm (L) due to the potential for small cracks to be present on the rods. The small cracks on the rods used in implants could cause reduced strength of these affected implants, and lead to patient injury.accessdata.fda.gov
April 22, 201674031Class IITerminatedStreamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.Potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip, resulting in possible patient injury.accessdata.fda.gov
March 18, 201673659Class IITerminatedRTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw DriverMultiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use.accessdata.fda.gov
May 29, 201571474Class IITerminatedSonger Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated.The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile, distributed by DePuy Spine Inc.accessdata.fda.gov
May 21, 201571424Class IITerminatedBullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 008464680Three lots of the Bullet -Tip VBR 13mm x 32 mm implants are mislabeled with a light green colored label, used for 16 mm trial instead of a lime green label, used for a 13 mm trial.accessdata.fda.gov
June 11, 201468619Class IITerminatedTritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation fLack of Sterility Assuranceaccessdata.fda.gov
October 7, 201367093Class IITerminatedC-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to promote fusion in orderAs the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling as a partial Vertebral Body Replacement Device (VBR). While the use of this device as a partial VBR is unlikely due to the size of the device, use of this deviaccessdata.fda.gov
June 14, 201369036Class IITerminatedStreamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to sThe affected fixed rod holders did not allow the instrument to lock down on the spinal rod.accessdata.fda.gov
September 10, 201269033Class IITerminatedSTREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLYSome set screw thread profiles were found not to be within specifications.accessdata.fda.gov
October 10, 200745526Not yet classifiedTerminatedPioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.accessdata.fda.gov
March 3, 200634922Not yet classifiedTerminatedZimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-049-50. Manufactured by Pioneer Surgical Technology, Marquette, MI; Distributed by Zimmer, Warsaw, IN.There may be an obstruction in the cannula that will prevent the guide wire from passing through it. The obstruction in the cannula can force the guidewire to advance further into the patient than intended.accessdata.fda.gov
July 29, 200532949Not yet classifiedTerminatedPioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.Screw may be incorrectly etched as to length.accessdata.fda.gov
July 29, 200532918Not yet classifiedTerminatedPioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP.The product has a higher than normal locking torque, which may cause the saddle to malfunction or to break interoperatively.accessdata.fda.gov
January 20, 200428213Not yet classifiedTerminatedStayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001.Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.accessdata.fda.gov
May 28, 200326405Not yet classifiedTerminatedStayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by ZimmerLabel may bear an incorrect part number [2227-02-02] and size [03.8MM].accessdata.fda.gov

Compare with other makers

Updated July 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.