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510(k) K875054

Device
ACROMED ADS BONE NAIL DRIVER
Applicant
BUCKMAN CO., INC.
510(k) number
K875054
Product code
HWR  
Decision
Substantially Equivalent (SESE)
Decision date
1988-01-28
Date received
1987-12-09
Regulation
888.4540
Classification name
Driver, Prosthesis
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 HWR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K915776KNEE PROSTHESIS DRIVERKim-Med, Inc.1992-06-11
K870847SCHULTZ PHALANGEAL COMPONENT DRIVERWarsaw Orthopedic, Inc.1987-03-13
K870848SCHULTZ METACARPAL COMPONENT DRIVERWarsaw Orthopedic, Inc.1987-03-13

Legacy Summary#

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FDA Review#

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