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510(k) K812506

Device
THE ARTHROFILE
Applicant
DYONICS, INC.
510(k) number
K812506
Product code
HTR  
Decision
Substantially Equivalent (SESE)
Decision date
1981-09-24
Date received
1981-09-01
Regulation
878.4800
Classification name
Rasp
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
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

Other 510(k) Records For Product Code HTR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K870329ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202Biodynamic Technologies, Inc.1987-02-13
K870333BIODYNAMICS SMALL JOINT BRUSH #1203Biodynamic Technologies, Inc.1987-02-13
K870349BIODYNAMICS FEMORAL CANAL BRUSH #1201Biodynamic Technologies, Inc.1987-02-13
K813093RICHARDS ACETABULAR BRUSHRichard'S Medical Equip., Inc.1981-11-20
K780771MICRO RASPSAmsco Co.1978-05-16
K771016INTERMEDULLARY BRUSHHowmedica Corp.1978-01-12
K771745RASPS FOR SCRAPING BONEDepuy, Inc.1977-09-28
K760109PROSTHESIS, TOTAL HIP-RASPOrthopedic Equipment Co., Inc.1976-07-20

Legacy Summary#

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FDA Review#

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