PMT Posterior Cervical Stabilization System (PCSS)
Providence Medical Technology, Inc.
PROVIDENCE MEDICAL TECHNOLOGY, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009394448 | 3009394448 | PROVIDENCE MEDICAL TECHNOLOGY, INC. | 1 | N | 2026-01-01 | 4234 Hacienda Dr. Suite 150 Pleasanton CA US 94588 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 135290 | 1180097208 | K253676 | CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) | MRW | 2026-05-14 |
| 135290 | 1720843016 | K251060 | CORUS™ Navigation System-GX | OLO | 2025-07-30 |
| 135290 | 1772437077 | K241035 | PMT Posterior Cervical Stabilization System (PCSS) | MRW | 2024-06-25 |
| 135290 | 1571622410 | K240625 | CORUS Navigation Access System | OLO | 2024-05-03 |
| 135290 | 1633378424 | K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | MRW | 2023-12-19 |
| 135290 | 1016264747 | K230297 | PMT Expandable Cage (PMT EXP) | MRW | 2023-08-11 |
| 135290 | 1393609145 | K220951 | PMT Facet Fixation System (PMT FFS) | MRW | 2022-12-09 |
| 135290 | 1149024447 | K212636 | CORUS Spinal System-X | HRX | 2021-10-15 |
| 135290 | 1960432124 | K190201 | CORUS Spinal System | HRX | 2019-03-08 |
| 135290 | 1136975117 | K180876 | DTRAX Spinal System | HRX | 2018-05-18 |
| 135290 | 1778850548 | K172279 | PMT Posterior Fixation System | NKG | 2017-09-20 |
| 135290 | 1431301975 | K170698 | ALLY(TM) Bone Screws | HWC | 2017-05-31 |
| 135290 | 1462556378 | K163474 | CAVUX CervicalCage-L SA System | OVE | 2017-03-10 |
| 135290 | 1157415246 | K163374 | ALLY™ Facet Screws | MRW | 2017-02-16 |
| 135290 | 1710039875 | K122801 | PROVIDENCE CERVICAL CAGE | ODP | 2013-05-24 |
| 135290 | 1704770745 | K121713 | PMT BONE SCREWS | HWC | 2012-09-27 |
| 135290 | 1086478131 | ||||
| 135290 | 1598679261 | ||||
| 135290 | 1667430560 | ||||
| 135290 | 1712365826 | ||||
| 135290 | 1724368384 | ||||
| 135290 | 1755528453 | ||||
| 135290 | 1986824502 |
Product Codes Associated With Registrations#
PMN#
CORUS Navigation Access System
Providence Medical Technology, Inc.
PMT Facet Fixation System, Lumbar (PMT FFS-LX)
Providence Medical Technology, Inc.
PMT Expandable Cage (PMT EXP)
Providence Medical Technology, Inc.
CORUS Spinal System-X
Providence Medical Technology, Inc.
PMT Facet Screw
Providence Medical Technology, Inc.
CORUS Spinal System
Providence Medical Technology, Inc.
DTRAX Spinal System
Providence Medical Technology, Inc.
PMT Posterior Fixation System
Providence Medical Technology, Inc.
ALLY(TM) Bone Screws
Providence Medical Technology, Inc.
CAVUX CervicalCage-L SA System
PROVIDENCE MEDICAL TECHNOLOGY, INC.
ALLY™ Facet Screws
PROVIDENCE MEDICAL TECHNOLOGY, INC.
PROVIDENCE CERVICAL CAGE
PROVIDENCE MEDICAL TECHNOLOGY, INC.
PMT BONE SCREWS
PROVIDENCE MEDICAL TECHNOLOGY, INC.
GUDID#
CORUS NAVIGATION ACCESS SYSTEM-GLX - The CORUS™ Navigation Access System-GLX disposable instruments are used during the preparation and usage of CORUS™ Spinal System-LX during spinal surgery to assist the surgeon in locating anatomical structures, such as the facet joint, in either open or minimally invasive procedures.
2025-11-03
CORUS-LX Implant, 4mm - The CAVUX Cage-LX is used in conjunction with ALLY Bone ScrewLX as an integrated construct referred to as the CORUS-LX Implant.The device achieves facet fixation by spanning the facet interspacewith points of fixation at each end of the construct. The deviceprovides rigid fixation as an adjunct to fusion with the bone screwproviding additional anchoring into cortical bone.The titanium constructs are offered in various footprints and heightsand are manufactured from implant grade titanium alloy (6Al-4V Ti).CORUS-LX Implant is single-use only, provided sterile (gammasterilized) with pre-attached, disposable, delivery handles. CORUSLX Implant should be implanted only using the CORUS™ SpinalSystem-LX.
2025-08-13
CORUS-LX Implant, 5mm - The CAVUX Cage-LX is used in conjunction with ALLY Bone ScrewLX as an integrated construct referred to as the CORUS-LX Implant.The device achieves facet fixation by spanning the facet interspacewith points of fixation at each end of the construct. The deviceprovides rigid fixation as an adjunct to fusion with the bone screwproviding additional anchoring into cortical bone.The titanium constructs are offered in various footprints and heightsand are manufactured from implant grade titanium alloy (6Al-4V Ti).CORUS-LX Implant is single-use only, provided sterile (gammasterilized) with pre-attached, disposable, delivery handles. CORUSLX Implant should be implanted only using the CORUS™ SpinalSystem-LX.
2025-08-13
CORUS-LX LevelOne, 4mm - Three related devices: CORUS-LX Implant, CORUS Spinal System-LX and DiViNE Portal System-LX, referred to as “CORUS-LX LevelOne” – which represents a combination of these devices.
2025-08-13
CAVUX Cage-LX, 5mm - The CAVUX Cage-LX is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. 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 prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system
2025-07-08
CAVUX Cervical Cage-T - The CAVUX Cervical Cage-T is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.
2015-09-02
CAVUX™ Cervical Cage-L 8x12x15mm 7 deg - CAVUXTM Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. 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 prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
2016-10-14
CAVUX™ Cervical Cage-B 5mm - CAVUX Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. 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 prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
2016-09-26
CORUS™ Spinal System - The CORUS Spinal System instruments are used to access and prepare the posterior cervical spine for joint fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of allograft or autograft in patients with or without anterior or posterior instrumentation. It is recommended that commercially available autograft or allograft be used to aid fusion. Autograft or allograft material is not supplied as part of the system.
2019-07-23
CORUS™ Allograft Delivery Instrument - A manual orthopedic surgical instrument used to deliver structural bone graft to a target area of the spine. The Allograft Delivery Instrument is manufactured using medical grade polycarbonate resin and stainless steel. The CORUS™ Allograft Delivery Instrument is intended and indicated for the delivery of structural bone graft to a target area of the spine.
2019-07-24
CAVUX™ Cervical Cage SE - CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX Cervical Cages are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). The implants are single-use only.
2019-07-23
CAVUX™ Cervical Cage SB - CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX® Cervical Cages are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). The implants are single-use only.
2019-07-23
CAVUX Cervical Cage-B - The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.
2015-09-02
DTRAX® Spinal System - The DTRAX® Spinal System is a set of instruments intended and indicated for access and preparation of a spinal joint to aid in fusion.
2017-06-27
CORUS Spinal System-X - DX-22-300
2020-06-12
CAVUX Cervical Cage-X - PD-31-203
2020-06-12
CAVUX™ Cervical Cage-L 6x12x15mm 7 deg - CAVUXTM Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. 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 prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
2016-10-14
CAVUX™ Cervical Cage-L 7x12x15mm 7 deg - CAVUX Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. 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 prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
2016-10-14
CAVUX™ Cervical Cage-L 9x12x15 mm 7 deg - CAVUX Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. 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 prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
2016-10-14
CAVUX™ Cervical Cage-L 10x12x15mm 7 deg - CAVUXTM Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. 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 prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
2016-10-14
CAVUX™ Cervical Cage-L 7x14x17mm - CAVUX™ Cervical Cage-L implants are titanium constructs offered in various heights. All CAVUX™ Cervical Cage-L implants are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). The implants are provided sterile and are single-use only.
2017-06-28
CAVUX™ Cervical Cage-L 8x14x17mm - CAVUX™ Cervical Cage-L implants are titanium constructs offered in various heights. All CAVUX™ Cervical Cage-L implants are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). The implants are provided sterile and are single-use only.
2017-06-28
CAVUX™ Cervical Cage-L 9x14x17mm - CAVUX™ Cervical Cage-L implants are titanium constructs offered in various heights. All CAVUX™ Cervical Cage-L implants are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). The implants are provided sterile and are single-use only.
2017-06-28
CAVUX™ Cervical Cage-L 10x14x17mm - CAVUX™ Cervical Cage-L implants are titanium constructs offered in various heights. All CAVUX™ Cervical Cage-L implants are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). The implants are provided sterile and are single-use only.
2017-06-28
CORUS PCSS Implant 4mm - CORUS™ PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments.
2025-02-19
CORUS PCSS Implant, 5mm - CORUS™ PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments.
2025-02-19
CORUS PCSS LevelOne, 4mm - Three related devices: CORUS PCSS Implant, CORUS Spinal System and DiViNE Portal System, referred to as “CORUS™ PCSS LevelOne” – which represents a combination of these devices.
2025-02-19
CAVUX CERVICAL CAGE-X, 5MM - CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX® Cervical Cages are manufactured from implant grade titanium alloy (6Al-4V Titanium). The implants are single-use only.
2024-11-13
CAVUX Cage-LX, 4mm - The CAVUX Cage-LX is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. 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 prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
2024-11-13
CAVUX Facet Fixation System, 4mm - CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct. CAVUX FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. CAVUX FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft.
2024-11-13
CAVUX Facet Fixation System, 5mm - CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct. CAVUX FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. CAVUX FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft.
2024-11-13
DTRAX Bone Screw - The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruction, osteotomy, arthrodesis, join fusion, fracture repair and fixation appropriate for the size of the device.
2015-09-15
DTRAX Cervical Cage-B - The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.
2015-09-15
DTRAX Cervical Cage-B - The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.
2015-09-03
DTRAX Cervical Cage-T - The DTRAX Cervical Cage-T is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.
2015-09-03
DTRAX Bone Screw - The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruction, osteotomy, arthrodesis, join fusion, fracture repair and fixation appropriate for the size of the device.
2015-09-03
ALLY Bone Screw - The ALLY Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruction, osteotomy, arthrodesis, join fusion, fracture repair and fixation appropriate for the size of the device.
2015-09-02
CAVUX™ Cervical Cage-L 6x14x17mm - CAVUX™ Cervical Cage-L implants are titanium constructs offered in various heights. All CAVUX™ Cervical Cage-L implants are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). The implants are provided sterile and are single-use only.
2017-06-28
ALLY Bone Screw-LX - The ALLY Bone Screw-LX is intended for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
2024-11-13
CORUS Spinal System-LX - CORUS™ Spinal System-LX is a sterile-packaged set of instruments for joint access, bone preparation, implant delivery, and bone graft application indicated for posterior lumbar fusion in patients with lumbar degenerative disc disease
2024-11-13