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510(k) Data Aggregation
K Number
K251885Device Name
CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
Manufacturer
Providence Medical Technology, Inc.
Date Cleared
2025-07-10
(20 days)
Product Code
MRW
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Providence Medical Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K241035Device Name
PMT Posterior Cervical Stabilization System (PCSS)
Manufacturer
Providence Medical Technology, Inc.
Date Cleared
2024-06-25
(70 days)
Product Code
MRW
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Providence Medical Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PMT Posterior Cervical Stabilization System (PCSS) is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments.
PMT PCSS is placed through a posterior surgical approach in up to 3 consecutive levels of the cervical spine (C3-C7) and achieves bilateral facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct.
PMT PCSS is intended as an adjunct to posterior cervical fusion (PCF) and is only intended to be used in combination with an anterior cervical discectomy and fusion (ACDF) at the same level(s).
PMT PCSS is indicated for skeletally mature patients with degenerative disc disease (DDD). DDD is defined as radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies.
PMT PCSS is to be used with autogenous bone and/or allogenic bone graft.
Device Description
PMT PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. The device is placed through a posterior surgical approach in up to 3 consecutive levels of the cervical spine (C3-C7) and achieves bilateral facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct.
The device is manufactured from medical grade titanium alloy (6A14V) and supplied sterile for single use only with a pre-attached disposable delivery instruments. The implant is fenestrated and is to be used with autogenous bone and/or allogenic bone graft. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone.
CORUS® Spinal System is used to access and prepare the site for posterior fusion.
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K Number
K240625Device Name
CORUS Navigation Access System
Manufacturer
Providence Medical Technology, Inc.
Date Cleared
2024-05-03
(58 days)
Product Code
OLO
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Providence Medical Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CORUS™ Navigation Access System for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUSTM Navigation Access System is specifically designed for use with the Medtronic StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
Device Description
The CORUS™ Navigation Access System is a manually operated disposable instrument set to be used with the Medtronic StealthStation™ System to assist the surgeon in precise site preparation during open or minimally invasive spinal surgery. The CORUS™ Navigation Access System includes the Navigated Access Chisel, Guide Tube, and Trephine Decorticator. The instruments are manufactured from stainless steel.
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K Number
K212636Device Name
CORUS Spinal System-X
Manufacturer
Providence Medical Technology, Inc.
Date Cleared
2021-10-15
(57 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
Providence Medical Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Cervical Fusion:
CORUSTM System-X is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.
For Lumbar Fusion:
CORUSTM Spinal System-X is a set of instruments indicated to be used to perform posterior lumbar fusion in patients with lumbar degenerative disc disease.
Device Description
The CORUS™ Spinal System-X is a set of instruments indicated for performing posterior cervical or lumbar fusion. The instruments will be supplied sterile and single use only. The system consists of:
- Access Chisel
- Access Chisel Handle
- Trephine Decorticator
- Guide Tube
- Rasp Decorticator
- Rotary Decorticator
- Bone Graft Tamp
- Multi-Tool
- Guide Tube Adapter
These instruments allow the user to access the posterior cervical or lumbar spine to perform posterior fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of autograft or allograft.
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K Number
K183589Device Name
PMT Facet Screw
Manufacturer
Providence Medical Technology, Inc.
Date Cleared
2019-10-11
(294 days)
Product Code
MRW
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Providence Medical Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PMT Facet Screw is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The PMT Facet Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1. The PMT Facet Screw is indicated for treatment of any or all of the following:
1. Pseudoarthrosis and failed previous fusion
2. Spondylolisthesis
3. Spondylolysis
4. Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies
5. Degeneration of the facets with instability; and
6. Fracture
The PMT Facet Screw is intended for conventional or tissue-sparing surgical placement.
Device Description
The PMT Facet Screw is available in fully threaded configurations with diameters of 3.5 mm, 3.75 mm and 4.0 mm and lengths of 13 mm to 25 mm (in 2 mm increments). The PMT Facet Screw is constructed of Titanium-6 Aluminum- 4 Vanadium ELI alloy (conforming to ASTM F136-13) and supplied sterile for single use only.
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K Number
K190201Device Name
CORUS Spinal System
Manufacturer
Providence Medical Technology, Inc.
Date Cleared
2019-03-08
(32 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
Providence Medical Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CORUS Spinal System is a set of instruments to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.
Device Description
The CORUS™ Spinal System is a set of surgical instruments indicated for performing posterior cervical fusion. The instruments will be supplied sterile and single use only. The system consists of Access Chisel, Access Chisel Handle, Decortication Trephine, Guide Tube, Decortication Rasp, Decortication Burr, Bone Graft Tamp and a Fork Mallet. In combination, these instruments allow the user to access the posterior cervical spine to perform posterior cervical fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of autograft or allograft.
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K Number
K180876Device Name
DTRAX Spinal System
Manufacturer
Providence Medical Technology, Inc.
Date Cleared
2018-05-18
(45 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
Providence Medical Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DTRAX Spinal System is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.
Device Description
The DTRAX® Spinal System is a set of surgical instruments indicated for performing posterior cervical fusion. The instruments will be supplied sterile and single use only. The system consists of a facet joint access tool, lateral mass decortication trephine, mallet, cannula, decortication rasp, decortication burr, and tamp. In combination, these instruments allow the user to access the posterior cervical spine to perform posterior cervical fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of autograft or allograft.
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K Number
K172279Device Name
PMT Posterior Fixation System
Manufacturer
Providence Medical Technology, Inc.
Date Cleared
2017-09-20
(54 days)
Product Code
NKG
Regulation Number
888.3075Why did this record match?
Applicant Name (Manufacturer) :
Providence Medical Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PMT Posterior Fixation System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1 to T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The PMT Posterior Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
Device Description
The PMT Posterior Fixation System is a bone screw and rod construct that will be supplied sterile and single use only. It consists of polyaxial screws, fixation rods, and locking set screws. The polyaxial screws are designed to be utilized for pedicle fixation or anchored to the posterior lateral mass of the cervical (C1 to C7) and thoracic (T1 to T3) vertebra. A set screw is used to connect and anchor the rod to each screw head while locking the orientation of the polyaxial screw.
The PMT Posterior Fixation System is manufactured from 6Al-4V Titanium Alloy, conforming to ASTM F136. The polyaxial screw, available in diameters of 3.5mm and 4.0mm, is self-tapping with a range of screw lengths between 8mm to 24mm. The rod is offered in two diameters, 3.5mm and 3.8mm, with a range in lengths of 15mm to 240mm. The screw head that is assembled to the polyaxial screw accepts the 3.5mm or 3.8mm rod. The set screw comes in one size and has a matching thread profile to the screw head.
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K Number
K170698Device Name
ALLY(TM) Bone Screws
Manufacturer
Providence Medical Technology, Inc.
Date Cleared
2017-05-31
(85 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Providence Medical Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ALLY™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Device Description
The ALL Y™ Bone Screws are fully threaded cortical screws offered in various diameters and lengths. All screws are manufactured from titanium alloy. The implants are single use only.
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K Number
K163474Device Name
CAVUX CervicalCage-L SA System
Manufacturer
PROVIDENCE MEDICAL TECHNOLOGY, INC.
Date Cleared
2017-03-10
(88 days)
Product Code
OVE
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
PROVIDENCE MEDICAL TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CAVUX™ Cervical Cage-L SA System is indicated for standalone use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment with the device.
CAVUX™ Cervical Cage-L is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
CAVUX™ Cervical Cage-L must be used with ALLY™ Bone Screw-L while serving as a standalone system, and as such requires no additional supplementary fixation systems.
Device Description
The Providence Medical Technology, Inc. CAVUX™ Cervical Cage-L SA System is supplied terminally sterilized and is single-use only. The subject device is manufactured from medical grade titanium and is available in various sizes. Subject device is a rectangular hollow box shape with space for allogenic and autogenous bone graft and teeth on the inferior and superior surfaces of the implant. Self-drilling and self-tapping screws are provided as part of the subject device.
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