ADD-ON CONDYLE

Prosthesis, Condyle, Mandibular, Temporary

WALTER LORENZ SURGICAL, INC.

The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Add-on Condyle.

Pre-market Notification Details

Device IDK002790
510k NumberK002790
Device Name:ADD-ON CONDYLE
ClassificationProsthesis, Condyle, Mandibular, Temporary
Applicant WALTER LORENZ SURGICAL, INC. 11520 TRADEPORT DR. Jacksonville,  FL  32218 -2480
ContactTrevor Byrd
CorrespondentTrevor Byrd
WALTER LORENZ SURGICAL, INC. 11520 TRADEPORT DR. Jacksonville,  FL  32218 -2480
Product CodeNEI  
CFR Regulation Number872.4770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-07
Decision Date2001-08-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841036091507 K002790 000
00841036009847 K002790 000
00841036009830 K002790 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.