FDA.reportPublic FDA data

510(k) K915776

Device
Knee Prosthesis Driver
Applicant
KIM-MED, INC.
510(k) number
K915776
Product code
HWR
Decision
Substantially Equivalent (SESE)
Decision date
1992-06-11
Date received
1991-12-24
Regulation
888.4540
Classification name
Driver, Prosthesis
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM W BOHN
Address
1407 Kansas Ave. Kansas City MO US 64127 64127

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
K875054ACROMED ADS BONE NAIL DRIVERBuckman Co., Inc.1988-01-28
K870847SCHULTZ PHALANGEAL COMPONENT DRIVERWarsaw Orthopedic, Inc.1987-03-13
K870848SCHULTZ METACARPAL COMPONENT DRIVERWarsaw Orthopedic, Inc.1987-03-13