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510(k) K883457

Device
ASST-3000 SPINAL SURGERY TABLE
Applicant
ORTHOPEDIC SYSTEMS, INC.
510(k) number
K883457
Product code
FWY  
Decision
Substantially Equivalent (SESE)
Decision date
1988-08-26
Date received
1988-08-12
Regulation
878.4950
Classification name
Table, Operating-room, Non-electrical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROBERT R MOORE
Address
1897 National Ave. Hayward CA US 94545 94545

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FWY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K873478SKYTRON MODEL 130 SURGICAL TABLESkytron, Div. the Kmw Group, Inc.1987-09-24
K833509CHEMONUCLEOLYSIS TABLEStryker Corp.1983-11-28
K800118CHICK SURGICAL TABLEWarner-Lambert Co.1980-02-05

Legacy Summary#

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FDA Review#

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