FDA.reportPublic FDA data

510(k) K953961

Device
OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM
Applicant
OSTEONICS CORP.
510(k) number
K953961
Product code
FWW  
Decision
Substantially Equivalent (SESE)
Decision date
1995-11-29
Date received
1995-08-22
Regulation
878.4960
Classification name
Table, Operating-room, Pneumatic
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TERRY JAROSZ
Address
59 Rte. 17 Allendale NJ US 07401 07401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FWW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K935356CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLESAmsco American Sterilizer Co.1994-03-23
K931876FISK ARM SUPPORTVvortex International Corp.1993-09-09
K924713UNIVERSAL SURGICAL INSTRUMENT HOLDERT. Korossurgical Instruments Corp.1993-05-17
K863161TABLE, OPERATING ROOM, HYDRAULICKamiya Tsusan Kaisha, Ltd.1986-09-05
K853479SKYTRON ELITE 300 SURGERY TABLESkytron, Div. the Kmw Group, Inc.1985-09-05

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