BUCKET PROSTHESIS PORP

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 Bucket Prosthesis Porp.

Pre-market Notification Details

Device IDK883727
510k NumberK883727
Device Name:BUCKET PROSTHESIS PORP
ClassificationProsthesis, Partial Ossicular Replacement
Applicant TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis,  TN  38103
ContactThomas, Jr
CorrespondentThomas, Jr
TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis,  TN  38103
Product CodeETB  
CFR Regulation Number874.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-31
Decision Date1989-01-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00681490035859 K883727 000
00763000035525 K883727 000
00763000035532 K883727 000
00763000035549 K883727 000
00763000035556 K883727 000
00763000035563 K883727 000
00681490034593 K883727 000
00681490035804 K883727 000
00681490035811 K883727 000
00681490035828 K883727 000
00681490035835 K883727 000
00681490035842 K883727 000
00763000035518 K883727 000

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