FDA.reportPublic FDA data

510(k) K941128

Device
OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS
Applicant
OSTEONICS CORP.
510(k) number
K941128
Product code
BXB  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1994-12-08
Date received
1994-03-09
Regulation
890.5380
Classification name
Exerciser, Powered
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROBERT A KOCH, J.D
Address
59 Rte. 17 Allendale NJ US 07401 07401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BXB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K072887G-TRAINER MEDICALAlter-G, Inc.2008-01-25
K003272FLO-BOOTDiscovery Group, LLC2001-04-04
K952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.1996-09-25
K953456E-Z FLEXFluid Motion Biotechnologies, Inc.1996-01-26
K955105BTE CPM-10Baltimore Therapeutic Equipment Co.1995-12-29
K955106BTE CPM-20Baltimore Therapeutic Equipment Co.1995-12-29
K950755FLEXMATE K500Breg, Inc.1995-10-05
K945733AQUAHAB, MODEL 120-72-101Aquarius Electronics, Inc.1995-09-15
K951029HAMEX ONENorthern Orthopaedic Products, Inc.1995-09-15
K950682W2 WRIST CPM UNITToronto Medical Corp.1995-09-13
K952369KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLEPhysicians Consulting, Inc.1995-08-07
K945690BACKCYCLER CPM(TM)Ergomedics, Inc.1995-06-22
K946169ACTIC 2002North Atlantic Rehabilitation, Inc.1995-06-15
K945824GALAXY MD SERIES THERAPYPOOLSGalaxy Aquatics, Inc.1995-04-05
K944819KRDL 2000Physicians Consulting, Inc.1995-03-10

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