Data / Medical devices / United States / Providence Medical Technology, Inc.

Providence Medical Technology, Inc.: FDA-registered device maker in Pleasanton, CA, United States, 10 510(k) clearances

Name: Providence Medical Technology, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Providence Medical Technology, Inc. is registered with the FDA (registration 3009394448) in Pleasanton, CA, United States. It lists 8 device types. The FDA files 10 510(k) clearances under its listings, the newest dated June 18, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3009394448
Address: 4234 Hacienda Dr. Suite 150, Pleasanton, CA, United States, 94588
Owner or operator: Providence Medical Technology, Inc. (10038884)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: June 11, 2013
Registered through: 2027
Brand names listed: ALLY Bone Screw, ALLY Bone Screw-LX, CAVUX CAGE-EXP, CAVUX Cage-LX, CAVUX Expandable Cage, CAVUX FFS-LX, CAVUX® Cage-LX, CAVUX® Cervical Cage-B and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Traction, Non-Powered	HST	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Arthroscope	HRX	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Retractor	GAD	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Support, Patient Position	CCX	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, Facet Screw Spinal Device	MRW	U	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 18, 2026	K261665	CORUS Navigation System-GN	OLO	Substantially Equivalent	Providence Medical Technology, Inc.	accessdata.fda.gov
May 14, 2026	K253676	CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D)	MRW	Substantially Equivalent	Providence Medical Technology, Inc.	accessdata.fda.gov
July 30, 2025	K251060	CORUS Navigation System-GX	OLO	Substantially Equivalent	Providence Medical Technology, Inc.	accessdata.fda.gov
June 25, 2024	K241035	PMT Posterior Cervical Stabilization System (PCSS)	MRW	Substantially Equivalent	Providence Medical Technology, Inc.	accessdata.fda.gov
May 3, 2024	K240625	CORUS Navigation Access System	OLO	Substantially Equivalent	Providence Medical Technology, Inc.	accessdata.fda.gov
December 19, 2023	K230840	PMT Facet Fixation System, Lumbar (PMT FFS-LX)	MRW	Substantially Equivalent	Providence Medical Technology, Inc.	accessdata.fda.gov
August 11, 2023	K230297	PMT Expandable Cage (PMT EXP)	MRW	Substantially Equivalent	Providence Medical Technology, Inc.	accessdata.fda.gov
March 8, 2019	K190201	CORUS Spinal System	HRX	Substantially Equivalent	Providence Medical Technology, Inc.	accessdata.fda.gov
May 31, 2017	K170698	ALLY(TM) Bone Screws	HWC	Substantially Equivalent	Providence Medical Technology, Inc.	accessdata.fda.gov
May 24, 2013	K122801	PROVIDENCE CERVICAL CAGE	ODP	Substantially Equivalent	Providence Medical Technology, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 29, 2019	85111	Class II	Terminated	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 in	There may be dimensional manufacturing error that represents a potential safety risk to patients.	accessdata.fda.gov

Compare with other makers

Updated June 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.