Medical Device Manufacturer · US , Ponte Vedra , FL

Treace Medical Concepts, Inc.

15 submissions · 15 cleared · Since 2015
15
Total
15
Cleared
0
Denied

Treace Medical Concepts, Inc. — FDA 510(k) Submissions

Treace Medical Concepts, Inc. has submitted 15 FDA 510(k) premarket notifications since 2015, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plate, Fixation, Bone, Screw, Fixation, Bone . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
Treace Medical Concepts (TMC) Screw Fixation System
K260361 · HWC Screw, Fixation, Bone · Orthopedic
Mar 2026 30d
Treace Medical Concepts (TMC) Screw Fixation System
K242671 · HWC Screw, Fixation, Bone · Orthopedic
Oct 2024 28d
Treace Medical Systems (TMC) Plating System
K240173 · HRS Plate, Fixation, Bone · Orthopedic
Feb 2024 30d
Treace Medical Concepts (TMC) Plating System
K221181 · HRS Plate, Fixation, Bone · Orthopedic
Jan 2023 255d
Treace Medical Concepts (TMC) Hammertoe Fixation System
K222564 · HWC Screw, Fixation, Bone · Orthopedic
Nov 2022 83d
Treace Medical Concepts (TMC) Plating System
K220136 · HRS Plate, Fixation, Bone · Orthopedic
Feb 2022 29d
Treace Medical Concepts (TMC) Screw Fixation System
K213036 · HWC Screw, Fixation, Bone · Orthopedic
Oct 2021 30d
Treace Medical Concepts (TMC) Plating System
K200961 · HRS Plate, Fixation, Bone · Orthopedic
May 2020 28d
Treace Medical Concepts (TMC) Plating System
K192504 · HRS Plate, Fixation, Bone · Orthopedic
Oct 2019 48d
Treace Medical Concepts (TMC) Snap-Off Screw System
K183363 · HWC Screw, Fixation, Bone · Orthopedic
Jun 2019 191d
Treace Medical Concepts (TMC) Plating System
K183321 · HRS Plate, Fixation, Bone · Orthopedic
Jan 2019 56d
PYTHON Plate Trial Instruments
K173930 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2018 83d
Treace Medical Concepts (TMC) Compression Screw System
K172617 · HWC Screw, Fixation, Bone · Orthopedic
Oct 2017 55d
Treace Medical Concepts (TMC) Plating System
K153531 · HRS Plate, Fixation, Bone · Orthopedic
Jan 2016 29d
Treace Medical Concepts(TMC) Plating System
K143717 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2015 80d
Filters
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