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510(k) K002790

Device
ADD-ON CONDYLE
Applicant
WALTER LORENZ SURGICAL, INC.
510(k) number
K002790
Product code
NEI  
Decision
Substantially Equivalent (SESE)
Decision date
2001-08-06
Date received
2000-09-07
Regulation
872.4770
Classification name
Prosthesis, Condyle, Mandibular, Temporary
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TREVOR BYRD
Address
11520 Tradeport Dr. Jacksonville FL US 32218 32218

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NEI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K133285STRYKER TEMPORARY CONDYLAR PROSTHESISStryker2014-04-09
K081747MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEMSynthes (Usa)2008-09-05
K063181SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEMSynthes (Usa)2007-01-05
K031701OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEMOsteomed LP2004-07-08
K990667KLS-MARTIN TEMPORARY CONDYLAR IMPLANTKLS-Martin L.P.2001-07-27
K990637SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEADSynthes (Usa)1999-10-22

Legacy Summary#

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FDA Review#

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