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510(k) K801594

Device
ACE FISCHER EXTERNAL FIXATION DEVICE
Applicant
ACE ORTHOPEDIC MANUFACTURING CO.
510(k) number
K801594
Product code
HXK  
Decision
Substantially Equivalent (SESE)
Decision date
1980-09-09
Date received
1980-07-14
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#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K860018FISCHER WIRE/PIN CLAMPBuckman Co., Inc.1986-02-07
K772388CONVERSE-GILLIES NEEDLE HOLDEREdward Weck, Inc.1978-01-20

Legacy Summary#

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FDA Review#

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