FISCH MODIFIED TEF-WIRE PISTON

Prosthesis, Partial Ossicular Replacement

TREACE MEDICAL, INC.

The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Fisch Modified Tef-wire Piston.

Pre-market Notification Details

Device IDK823429
510k NumberK823429
Device Name:FISCH MODIFIED TEF-WIRE PISTON
ClassificationProsthesis, Partial Ossicular Replacement
Applicant TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeETB  
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
00681490035538 K823429 000
00681490023436 K823429 000
00681490023429 K823429 000
00681490023412 K823429 000
00763000035433 K823429 000

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