510(k) K790501

Device
Pediatric Osteotomy System
Applicant
HOWMEDICA CORP.
510(k) number
K790501
Product code
KTT
Decision
Substantially Equivalent (SESE)
Decision date
1979-04-10
Date received
1979-03-13
Regulation
888.3030
Classification name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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