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Medical device manufacturer

Pioneer Surgical Technology, Inc.

Pioneer Surgical Technology, Inc. holds 95 FDA 510(k) clearances across 21 product codes. Median elapsed review time is 86 days. openFDA lists 10 recall records naming the company. FDA publishes it under 10 different spellings, all counted here as one company.

Updated · ingest status · JSON

510(k) clearances
95
Product codes
21
Median review
86 days
Recall records
10

How does FDA spell Pioneer Surgical Technology, Inc.?

FDA publishes this company under 10 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published itDatasetMatched by
PIONEER SURGICAL TECHNOLOGY, INC.device/recallnormalised
PIONEER SURGICAL TECHNOLOGY, INC.device/enforcementnormalised
Pioneer Surgical Technologydevice/recallnormalised
Pioneer Surgical Technologydevice/510knormalised
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Techdevice/510knormalised
Pioneer Surgical Technology, Inc.device/510knormalised
Pioneer Surgical Technology, Inc.device/registrationlistingnormalised
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)device/510knormalised

Showing 8 of 10.

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Pioneer Surgical Technology, Inc. file in?

21 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
JDQCerclage, Fixation1787 days
KWQAppliance, Fixation, Spinal Intervertebral Body1477 days
NKBThoracolumbosacral Pedicle Screw System1469 days
MQVFiller, Bone Void, Calcium Compound7137 days
HWCScrew, Fixation, Bone650 days
KWPAppliance, Fixation, Spinal Interlaminal6142 days
HRSPlate, Fixation, Bone590 days
MAXIntervertebral Fusion Device With Bone Graft, Lumbar5127 days
MNIOrthosis, Spinal Pedicle Fixation367 days
MQPSpinal Vertebral Body Replacement Device390 days
HTNWasher, Bolt Nut284 days
NKGPosterior Cervical Screw System232 days
NQWOrthosis, Spine, Plate, Laminoplasty, Metal224 days
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical2100 days
GEIElectrosurgical, Cutting & Coagulation & Accessories1133 days
GXZElectrode, Needle1204 days
HSBRod, Fixation, Intramedullary And Accessories158 days
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component159 days
MNHOrthosis, Spondylolisthesis Spinal Fixation1245 days
ODPIntervertebral Fusion Device With Bone Graft, Cervical176 days
OLOOrthopedic Stereotaxic Instrument1162 days

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has Pioneer Surgical Technology, Inc. had a recall?

openFDA lists 10 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.

  • Z-2076-2014Class IITerminatedJDQ

    Lack of Sterility Assurance

  • Z-2616-2014Class IITerminatedNKB

    The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.

  • Z-2573-2014Class IITerminatedKWP

    Some set screw thread profiles were found not to be within specifications.

  • Z-0291-2008TerminatedHWR

    The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.

  • Z-0872-06TerminatedHWC

    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.

Showing the 5 most recently initiated of 10.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has Pioneer Surgical Technology, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K261271Cable-Ready® Cable Grip SystemJDQ90
K251436Resolve Anterior Cervical Plate SystemKWQ64
K230993CODA™ Anterior Cervical Plate SystemKWQ75
K222493CODA™ Anterior Cervical Plate SystemKWQ92
K220244DVR® Crosslock Wrist Spanning Plate (131849181)HRS90
K211408CervAlign® Anterior Cervical Plate SystemKWQ48
K201497EVOS Cabling SystemJDQ145
K200513DAC Dynamic Active Compression PlateHRS142
K200095Streamline Navigated InstrumentsOLO162
K193468Tritium Sternal Cable Plate SystemJDQ87

Source: openFDA device/510k · retrieved

Where is Pioneer Surgical Technology, Inc. registered?

FDA lists 1 registered establishment for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.

Watch what Pioneer Surgical Technology, Inc. files next

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.