FDA.reportPublic FDA data

TREACE MEDICAL CONCEPTS, INC.

Matched from indexed company URL: Treace Medical Concepts

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30116239943011623994TREACE MEDICAL CONCEPTS, INC.1Y2026-01-01100 Palmetto Park Place PONTE VEDRA FL US 32081

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1865151385974030K260361Treace Medical Concepts (TMC) Screw Fixation SystemHWC2026-03-06
1865151650404561K251135Treace Medical Concepts (TMC) Implant Fixation SystemHRS2025-08-21
1865151631461644K243658TMC Compression Implant SystemJDR2024-12-26
1865151214379832K242671Treace Medical Concepts (TMC) Screw Fixation SystemHWC2024-10-04
1865151659058805K242415TMC Compression Implant SystemJDR2024-09-06
1865151796146173K240173Treace Medical Systems (TMC) Plating SystemHRS2024-02-22
1865151344791178K232387Treace Medical Concepts (TMC) Compression Implant SystemJDR2023-08-28
1865151591502978K222645Treace Medical Concepts (TMC) Implant Fixation SystemJDR2022-11-21
1865151800973362K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemHWC2022-11-15
1865151240041178K220717RedPoint Medical's Better Bunion SystemPBF2022-06-09
1865151050182498K220136Treace Medical Concepts (TMC) Plating SystemHRS2022-02-16
1865151019811348K213036Treace Medical Concepts (TMC) Screw Fixation SystemHWC2021-10-21
1865151537100556K200961Treace Medical Concepts (TMC) Plating SystemHRS2020-05-08
1865151724286261K192504Treace Medical Concepts (TMC) Plating SystemHRS2019-10-30
1865151926958376K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemHWC2019-06-13
1865152042196053K183321Treace Medical Concepts (TMC) Plating SystemHRS2019-01-25
1865151516805297K172617Treace Medical Concepts (TMC) Compression Screw SystemHWC2017-10-25
1865151149442651K153531Treace Medical Concepts (TMC) Plating SystemHRS2016-01-07
1865151689440875K143717Treace Medical Concepts(TMC) Plating SystemHRS2015-03-19
1865151187693859
1865151501777553
1865151006888211
1865151126067831
1865151215649570
1865151263851733
1865151421263896
1865151429116509
1865151454639270
1865151687595643
1865151723150253
1865151834399137
1865151836740093
1865151851467210
1865151858917959
1865151896775637
1865151907787848
1865151908361035
1865151930048748
1865151947818067
1865151989397097
1865152037877453

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS82025-08-21
HWC62026-03-06
JDR42024-12-26
PBF12022-06-09

PMN#

GUDID#

80 records. Showing 1-40. Next