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510(k) K870126

Device
FEMUR WRENCH
Applicant
ORTHOPEDIC SYSTEMS, INC.
510(k) number
K870126
Product code
GEG  
Decision
Substantially Equivalent (SESE)
Decision date
1987-02-03
Date received
1987-01-12
Regulation
878.4800
Classification name
Elevator, Surgical, General & Plastic Surgery
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 GEG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K891894ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSEZinnanti Surgical Instruments, Inc.1989-04-12
K891899ELEVATORS, VARIOUS TYPESZinnanti Surgical Instruments, Inc.1989-04-12
K890365SEPTUM ELEVATORKinetic Medical Products1989-02-03
K890230LIGATURE NEEDLESKinetic Medical Products1989-01-27
K890253SURGICAL ELEVATORKinetic Medical Products1989-01-27
K8724911.1 TWIST DRILLS AND 1.2 CORTICAL DRILLSMicro-Aire Surgical Instruments, Inc.1987-07-16
K870781ACROMED WALLIE-HEINIG DISECTOR/ELEVATORSBuckman Co., Inc.1987-03-09
K870591ELEVATOR, COBB SPINALMilitary Engineering, Inc.1987-02-26
K864421RAYLOR(TM) PERIOSTEAL ELEVATORSCedar Surgical, Inc.1986-11-26
K834176H.R. JAKOBI SURG. INSTRUMENTS 40/41Imm Enterprises , Ltd.1984-01-27
K781449HARRINGTON SPINAL ELEVATOROrthopedic Equipment Co., Inc.1978-09-27

Legacy Summary#

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FDA Review#

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