TOTAL

Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene

TREACE MEDICAL, INC.

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

Pre-market Notification Details

Device IDK822367
510k NumberK822367
Device Name:TOTAL
ClassificationReplacement, Total Ossicular, Prosthesis, Porous, Polyethylene
Applicant TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLBN  
CFR Regulation Number874.3495 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-06
Decision Date1982-09-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00681490035460 K822367 000
00681490035453 K822367 000
00681490035446 K822367 000
00681490035439 K822367 000
00681490035422 K822367 000
00681490035415 K822367 000
00681490035408 K822367 000
00763000035389 K822367 000
00763000035372 K822367 000

Trademark Results [TOTAL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TOTAL
TOTAL
98401236 not registered Live/Pending
Raynor-Dyson, Jakima M.
2024-02-11
TOTAL
TOTAL
98401236 not registered Live/Pending
Epps, Keisha
2024-02-11
TOTAL
TOTAL
97550766 not registered Live/Pending
Suzhou Dake Machinery Co., Ltd.
2022-08-16
TOTAL
TOTAL
97342709 not registered Live/Pending
VenaCore Inc
2022-04-01
TOTAL
TOTAL
97311502 not registered Live/Pending
Colgate-Palmolive Company
2022-03-14
TOTAL
TOTAL
97180400 not registered Live/Pending
Alcon Inc.
2021-12-20
TOTAL
TOTAL
88585130 not registered Live/Pending
Clarke, Alexander
2019-08-20
TOTAL
TOTAL
88114498 not registered Dead/Abandoned
Meyer Intellectual Properties Limited
2018-09-12
TOTAL
TOTAL
87899912 5752965 Live/Registered
Total Retail Group, LLC
2018-04-30
TOTAL
TOTAL
87436773 5384214 Live/Registered
Innovelis, Inc.
2017-05-04
TOTAL
TOTAL
87273740 not registered Dead/Abandoned
Meyer Intellectual Properties Limited
2016-12-19
TOTAL
TOTAL
86603202 4859189 Live/Registered
Raynor-Dyson, Jakima
2015-04-20
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