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510(k) K861576

Device
SHORTENING OSTEOTOMY GUIDE
Applicant
OSTEOTOMY GUIDE CO.
510(k) number
K861576
Product code
HTH  
Decision
Substantially Equivalent (SESE)
Decision date
1986-05-12
Date received
1986-04-28
Regulation
888.4600
Classification name
Protractor
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM REESE
Address
1450 S. Dobson Rd. Suite 201 Mesa AZ US 85202 85202

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HTH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K841470REESE OSTEOTOMY GUIDE SYSOsteotomy Guide Co.1984-05-23
K822305ORTHO-LEVELFrontier Products1982-08-20

Legacy Summary#

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FDA Review#

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