PROVIDENCE MEDICAL TECHNOLOGY, INC.

Address:4234 Hacienda Dr. Suite 150,Pleasanton,CA,94588,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (3) Arthroscope (HRX) (2) Orthopedic Manual Surgical Instrument (LXH) (2) Screw, Fixation, Bone (HWC) (2) Apparatus, Traction, Non-Powered (HST) (1)

Premarket Exempt

No Yes

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CORUS™ Spinal System - 00852776006430 Catalog Number :

Device Description : The CORUS Spinal System instruments are used to access and prepare the posterior 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.

Device Class :

Duns Number: 969820245

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

CORUS™ Allograft Delivery Instrument - 00852776006454 Catalog Number :

Device Description : A manual orthopedic surgical instrument used to deliver structural bone graft t 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.

Device Class :

Duns Number: 969820245

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

CAVUX Cervical Cage-X - 00852776006492 Catalog Number : PD-31-203

Device Class :

Duns Number: 969820245

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

CORUS Spinal System-X - 00852776006508 Catalog Number : DX-22-300

Device Class : 2

Duns Number: 969820245

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

CORUS Guide Tube Adapter - 00852776006515 Catalog Number : PD-04-470

Device Description : CORUS Guide Tube Adapter

Device Class : 1

Duns Number: 969820245

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

PMT Cervical Harness - 00852776006522 Catalog Number : PD-33-600

Device Description : The PMT Cervical Visualization Harness stretches to conform to the outer shoulde The PMT Cervical Visualization Harness stretches to conform to the outer shoulder while holding traction securely.It is used to achieve safe, effective traction on the shoulders for intraoperative cervical X-rays.

Device Class : 1

Duns Number: 969820245

Premarket Exempt : Yes

Product Code : HST

Prescription Use : No

Device Count : 1

DTRAX Cervical Cage-B - 10852776006000 Catalog Number : PD-31-200

Device Description : The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant 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.

Device Class : 2

Duns Number: 969820245

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

DTRAX Cervical Cage-T - 10852776006017 Catalog Number : PD-31-100

Device Description : The DTRAX Cervical Cage-T is a single-use, titanium alloy intervertebral implant 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.

Device Class : 2

Duns Number: 969820245

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

DTRAX Bone Screw - 10852776006024 Catalog Number : PD-32-301

Device Description : The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in 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.

Device Class : 2

Duns Number: 969820245

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

DTRAX Bone Screw - 20852776006021 Catalog Number :

Device Class : 2

Duns Number: 969820245

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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