AUSTIN MODIFIED TOTAL OSSICULAR REPLACE

Porous Polyethylene Ossicular Replacement

TREACE MEDICAL, INC.

The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Austin Modified Total Ossicular Replace.

Pre-market Notification Details

Device IDK823441
510k NumberK823441
Device Name:AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
ClassificationPorous Polyethylene Ossicular Replacement
Applicant TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLBM  
CFR Regulation Number874.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-11-16
Decision Date1982-12-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00681490035712 K823441 000
00681490035477 K823441 000
00763000035440 K823441 000
00763000035396 K823441 000

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