MCGEE MODIFIED STAINLESS STEEL 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 Mcgee Modified Stainless Steel Piston.

Pre-market Notification Details

Device IDK823440
510k NumberK823440
Device Name:MCGEE MODIFIED STAINLESS STEEL 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
00681490035682 K823440 000
00681490035569 K823440 000
00681490035200 K823440 000
00681490035194 K823440 000
00681490035187 K823440 000
00681490035170 K823440 000
20681490035211 K823440 000
00763000039806 K823440 000
00763000035341 K823440 000
00763000035334 K823440 000
00681490035576 K823440 000
00681490035583 K823440 000
00681490035675 K823440 000
00681490035668 K823440 000
00681490035651 K823440 000
00681490035644 K823440 000
00681490035637 K823440 000
00681490035620 K823440 000
00681490035613 K823440 000
00681490035606 K823440 000
00681490035590 K823440 000
00763000035310 K823440 000

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