PROVIDENCE MEDICAL TECHNOLOGY, INC.

FDA Device Registration & Listing · Pleasanton, CA, US · Registration 3009394448

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009394448
FEI Number
3009394448
Entity Name
PROVIDENCE MEDICAL TECHNOLOGY, INC.
City/State/Country
Pleasanton, CA, US
Establishment Address
4234 Hacienda Dr. Suite 150, Pleasanton, CA 94588, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Providence Medical Technology, Inc. (Owner Number: 10038884)
Owner / Operator Contact Address
4234 Hacienda Dr. Suite 150, Pleasanton, CA 94588, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K240625
PMA Number
N/A

All Registered Proprietary Names

CORUS PCSS 3D Implant CORUS PCSS 3D Level One ALLY Bone Screw ALLY Bone Screw-LX CORUS Navigation System-GX CORUS Posterior Cervical Stabilization System (PCSS) CORUS Posterior Cervical Stabilization System (PCSS) Level One CORUS Posterior Cervical Stabilization System (PCSS) Implant (4mm / 5mm) CORUS Spinal System-X CORUS Spinal System CAVUX® Cervical Cage-T CAVUX® Cervical Cage-B CAVUX® Cervical Cage-B 5mm CAVUX® Cervical Cage-SB CAVUX® Cervical Cage-SE CAVUX® Cervical Cage-X CAVUX® Cage-LX CAVUX Expandable Cage CAVUX CAGE-EXP PMT Cervical Harness Cervical Visualization Harness Cervical Harness CAVUX FFS-LX CAVUX Cage-LX CORUS-LX CORUS-LX LevelOne CORUS Navigation Access System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2026-05-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-03-18
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-09-04
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2024-07-30
HRX Arthroscope Orthopedic Class 2 888.1100 2019-03-11
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-06-11
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2023-08-14
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2021-07-21
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2026-03-24
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2024-01-09
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-09-17

Official Correspondent

Edward Liou

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Providence Medical Technology, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K173198 U&I Corporation Facet Screw Fixation System 2018-01-03
K121850 Choicespine, LP Typhoon(TM) Facet Screw Fixation System 2012-09-20
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2012 Osteomed, Lp 3885 Arapaho Rd Addison TX 75001 U
OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009394448. Last updated year: 2026. Please use registration number 3009394448 when referencing this establishment in official correspondence.
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