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510(k) K974406

Device
ORTHOPLAN
Applicant
ORTHO-GRAPHICS, INC.
510(k) number
K974406
Product code
HWT  
Decision
Substantially Equivalent (SESE)
Decision date
1998-02-18
Date received
1997-11-21
Regulation
888.4800
Classification name
Template
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PETER M STEVENS
Address
100 N. Medical Dr. # 4550 Saltlake UT US 84113 84113

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HWT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K960685ORTHODOC PREOPERATIVE PLANNER MODEL 500Integrated Surgical Systems, Inc.1997-01-17
K894228KRONNER SPHERICAL CUTTERSKronner Medical1990-07-23
K870843SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIAWarsaw Orthopedic, Inc.1987-05-27
K871323ARTHROSCOPIC MENISCAL SUTURE SYSTEMOrthopedic Systems, Inc.1987-05-01
K8303603M OSTEOTOMY GUIDE3M Company1983-03-01
K811205MOLDED POLYSULFONE TRIAL PROSTHESISShannon Group1981-05-21
K781091KNEE INSTRUMENTATION, CONDYLARBiomet, Inc.1978-07-17
K771709WORRELL TRIAL PATELLADepuy, Inc.1977-10-06
K771710WORRELL PATELLA TEMPLATEDepuy, Inc.1977-10-06

Legacy Summary#

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FDA Review#

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