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510(k) K870848

Device
SCHULTZ METACARPAL COMPONENT DRIVER
Applicant
WARSAW ORTHOPEDIC, INC.
510(k) number
K870848
Product code
HWR  
Decision
Substantially Equivalent (SESE)
Decision date
1987-03-13
Date received
1987-03-03
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
JAMES RITTER
Address
P.O. Box 1157 Warsaw IN US 46580 46580

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
K875054ACROMED ADS BONE NAIL DRIVERBuckman Co., Inc.1988-01-28
K870847SCHULTZ PHALANGEAL COMPONENT DRIVERWarsaw Orthopedic, Inc.1987-03-13

Legacy Summary#

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FDA Review#

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