FDA.report

510(k) K822367

Device
TOTAL
Applicant
TREACE MEDICAL, INC.
510(k) number
K822367
Product code
LBN  
Decision
Substantially Equivalent (SESE)
Decision date
1982-09-07
Date received
1982-08-06
Regulation
874.3495
Classification name
Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00763000913687Brackmann/PolycelMEDTRONIC XOMED, INC.2025-06-23
00763000035389Brackmann / Polycel®MEDTRONIC XOMED, INC.2021-11-07
00763000035372Moretz / Polycel®MEDTRONIC XOMED, INC.2021-11-07
00681490035460MoretzMEDTRONIC XOMED, INC.2015-07-01
00681490035453BrackmannMEDTRONIC XOMED, INC.2015-07-01
00681490035446MortezMEDTRONIC XOMED, INC.2015-07-01
00681490035439MortezMEDTRONIC XOMED, INC.2015-07-01
00681490035422MortezMEDTRONIC XOMED, INC.2015-07-01
00681490035415MortezMEDTRONIC XOMED, INC.2015-07-01
00681490035408Fischer Sprandel IIMEDTRONIC XOMED, INC.2015-07-01

Legacy Summary

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FDA Review

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