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510(k) K860018

Device
FISCHER WIRE/PIN CLAMP
Applicant
BUCKMAN CO., INC.
510(k) number
K860018
Product code
HXK  
Decision
Substantially Equivalent (SESE)
Decision date
1986-02-07
Date received
1986-01-03
Regulation
888.4540
Classification name
Holder, Needle; Orthopedic
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAVID W SCHLERF
Address
921 Calle Verde Martinez CA US 94553 94553

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HXK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K890167HOLDER, NEEDLEDhason Brothers, Inc.1989-02-03
K872989MICRINS NEEDLE HOLDERMicrins Surgical, Inc.1987-08-21
K801594ACE FISCHER EXTERNAL FIXATION DEVICEAce Orthopedic Manufacturing Co.1980-09-09
K772388CONVERSE-GILLIES NEEDLE HOLDEREdward Weck, Inc.1978-01-20

Legacy Summary#

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FDA Review#

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