Providence Medical Technology, Inc.
Pleasanton, CA, US
PROVIDENCE MEDICAL TECHNOLOGY, INC. appears in FDA device records in Pleasanton, CA. FDA records list 21 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Providence Medical Technology, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- PROVIDENCE MEDICAL TECHNOLOGIESenforcement report, recall
510(k) clearance history
FDA records hold 21 510(k) clearances for Providence Medical Technology, Inc. between 2012 and 2026. The busiest year on record is 2017, with 4. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2013 | 1 |
| 2016 | 1 |
| 2017 | 4 |
| 2018 | 1 |
| 2019 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 3 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261665 | CORUS™ Navigation System-GN | OLO | Substantially Equivalent | |
| K253676 | CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) | MRW | Substantially Equivalent | |
| K253190 | CORUS-LX Implant | MRW | Substantially Equivalent | |
| K251060 | CORUS™ Navigation System-GX | OLO | Substantially Equivalent | |
| K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant | MRW | Substantially Equivalent | |
| K241035 | PMT Posterior Cervical Stabilization System (PCSS) | MRW | Substantially Equivalent | |
| K240625 | CORUS Navigation Access System | OLO | Substantially Equivalent | |
| K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | MRW | Substantially Equivalent | |
| K230297 | PMT Expandable Cage (PMT EXP) | MRW | Substantially Equivalent | |
| K220951 | PMT Facet Fixation System (PMT FFS) | MRW | Substantially Equivalent | |
| K212636 | CORUS Spinal System-X | HRX | Substantially Equivalent | |
| K183589 | PMT Facet Screw | MRW | Substantially Equivalent | |
| K190201 | CORUS Spinal System | HRX | Substantially Equivalent | |
| K180876 | DTRAX Spinal System | HRX | Substantially Equivalent | |
| K172279 | PMT Posterior Fixation System | NKG | Substantially Equivalent | |
| K170698 | ALLY(TM) Bone Screws | HWC | Substantially Equivalent | |
| K163474 | CAVUX CervicalCage-L SA System | OVE | Substantially Equivalent | |
| K163374 | ALLY™ Facet Screws | MRW | Substantially Equivalent | |
| K161642 | CAVUX™ Cervical Cage | ODP | Substantially Equivalent | |
| K122801 | PROVIDENCE CERVICAL CAGE | ODP | Substantially Equivalent | |
| K121713 | PMT BONE SCREWS | HWC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009394448 | 3009394448 | PROVIDENCE MEDICAL TECHNOLOGY, INC. | 4234 Hacienda Dr. Suite 150, Pleasanton, CA 94588 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HSTApparatus, Traction, Non-Powered
- HRXArthroscope
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OLOOrthopedic Stereotaxic Instrument
- NKGPosterior Cervical Screw System
- GADRetractor
- HWCScrew, Fixation, Bone
- CCXSupport, Patient Position
- MRWSystem, Facet Screw Spinal Device
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2428-2020 | Ally Bone Screw - Product Usage: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. Screws are intended for single use only. L Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300, Pleasanton, CA 94588, Rx Only. | There may be dimensional manufacturing error that represents a potential safety risk to patients. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain