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510(k) K860356

Device
ORTHOBLEND POWERED BONE MILL
Applicant
ZIMMER, INC.
510(k) number
K860356
Product code
LYS  
Decision
Substantially Equivalent (SESE)
Decision date
1986-07-08
Date received
1986-01-30
Regulation
888.4540
Classification name
Bone Mill
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
HENRY A QUELLO
Address
P.O. Box 708 Warsaw IN US 46581 46581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LYS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K883183TRACER BONE MILLDe Medica Mfg., Inc.1988-10-12
K861164OSTEOMILL BONE GRINDERBiodynamic Technologies, Inc.1986-05-02
K860016AESCULAP BONE MILLAesculap Instruments Corp.1986-03-19

Legacy Summary#

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FDA Review#

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