FDA.reportPublic FDA data

510(k) K904156

Device
ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS
Applicant
ORIGIN MEDSYSTEMS, INC.
510(k) number
K904156
Product code
LZV  
Decision
Substantially Equivalent (SESE)
Decision date
1990-11-27
Date received
1990-09-07
Regulation
888.4580
Classification name
System, Cement Removal Extraction
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CHIN, M.D.
Address
1900 S. Norfolk St., Suite 312 San Mateo CA US 94403 94403

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LZV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K021502OSCAR, MODEL OE3000Orthosonics, Ltd.2002-06-06
K961101STRYKER CEMENT REMOVAL SYSTEMStryker Corp.1996-07-15
K930629ACRYL-X II SYSTEMSonokinetics, Inc.1994-01-21
K904180PROSTHETIC CEMENT REMOVEROrigin Medsystems, Inc.1990-11-20
K891472IMPLANT TECHNOLOGY BONE CEMENT EXTRACTORImplant Technology, Inc.1989-05-02
K890285PROSTHETIC CEMENT REMOVERAlbert K. Chin1989-04-19

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases