This page includes the latest FDA filings for Treace Medical Concepts Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3011623994 |
| FEI Number | 3011623994 |
| Name | TREACE MEDICAL CONCEPTS, INC. |
| Owner & Operator | Treace Medical Concepts, Inc. |
| Contact Address | 203 Fort Wade Rd, STE 150 Ponte Vedra FL 32081 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 203 FORT WADE RD STE 150 PONTE VEDRA, FL 32081 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| Treace Medical Concepts, Inc. | SpeedMTP Compression Screws | 2024-11-14 |
| Treace Medical Concepts, Inc. | MIS Beveled Screw | 2024-11-08 |
| Treace Medical Concepts, Inc. | MIS Beveled Screw | 2024-11-08 |
| Treace Medical Concepts, Inc. | MIS Beveled Screw | 2024-11-08 |
| Treace Medical Concepts, Inc. | MIS Beveled Screw | 2024-11-08 |
| Treace Medical Concepts, Inc. | MIS Beveled Screw | 2024-11-08 |
| Treace Medical Concepts, Inc. | MIS Beveled Screw | 2024-11-08 |
| Treace Medical Concepts, Inc. | MIS Beveled Screw | 2024-11-08 |
| Treace Medical Concepts, Inc. | Drill | 2024-11-08 |
| Treace Medical Concepts, Inc. | Drill | 2024-11-08 |
| Treace Medical Concepts, Inc. | Length Gage | 2024-11-08 |
| Treace Medical Concepts, Inc. | Elevator | 2024-11-08 |
| Treace Medical Concepts, Inc. | Guide Sleeve | 2024-11-08 |
| Treace Medical Concepts, Inc. | Guide Sleeve | 2024-11-08 |
| Treace Medical Concepts, Inc. | Ratchet Handle | 2024-11-08 |
| Treace Medical Concepts, Inc. | Nanoplasty System | 2024-10-28 |
| Treace Medical Concepts, Inc. | Nanoplasty System | 2024-10-28 |
| Treace Medical Concepts, Inc. | Nanoplasty System | 2024-10-28 |
| Treace Medical Concepts, Inc. | Nanoplasty System | 2024-10-23 |
| Treace Medical Concepts, Inc. | Nanoplasty System | 2024-10-23 |
| Treace Medical Concepts, Inc. | Lapiplasty SpeedPlate | 2024-10-07 |
| Treace Medical Concepts, Inc. | Instrument Tray | 2024-08-22 |
| Treace Medical Concepts, Inc. | Instrument Tray | 2024-08-22 |
| Treace Medical Concepts, Inc. | Drill Guide | 2024-07-18 |
| Treace Medical Concepts, Inc. | AO Driver Tip | 2024-06-12 |
| Treace Medical Concepts, Inc. | Scalpel | 2024-06-12 |
| Treace Medical Concepts, Inc. | Drill Guide | 2024-06-12 |
| Treace Medical Concepts, Inc. | Lapiplasty SpeedPlate | 2024-06-11 |
| Treace Medical Concepts, Inc. | Lapiplasty SpeedPlate | 2024-06-11 |
| Treace Medical Concepts, Inc. | Lapiplasty SpeedPlate | 2024-06-11 |
| Treace Medical Concepts, Inc. | Nanoplasty System | 2024-05-30 |
| Treace Medical Concepts, Inc. | Nanoplasty System | 2024-05-17 |
| Treace Medical Concepts, Inc. | Nanoplasty System | 2024-05-17 |
| Treace Medical Concepts, Inc. | Nanoplasty System | 2024-05-17 |
| Treace Medical Concepts, Inc. | Nanoplasty System | 2024-05-17 |
| Treace Medical Concepts, Inc. | Nanoplasty System | 2024-05-17 |
| Treace Medical Concepts, Inc. | Nanoplasty System | 2024-05-17 |
| Treace Medical Concepts, Inc. | Sizer | 2024-05-02 |
| Treace Medical Concepts, Inc. | Drill Bit | 2024-04-29 |
| Treace Medical Concepts, Inc. | K-Wire | 2024-04-29 |
| Treace Medical Concepts, Inc. | Cut Guide | 2024-04-29 |
| Treace Medical Concepts, Inc. | K-Wire Sleeve | 2024-04-29 |
| Treace Medical Concepts, Inc. | Screwdriver | 2024-04-29 |
| Treace Medical Concepts, Inc. | Cut Guide | 2024-04-29 |
| Treace Medical Concepts, Inc. | Screwdriver | 2024-04-29 |
| Treace Medical Concepts, Inc. | Screwdriver | 2024-04-29 |
| Treace Medical Concepts, Inc. | Cut Guide | 2024-04-19 |
| Treace Medical Concepts, Inc. | Cut Guide | 2024-04-19 |
| Treace Medical Concepts, Inc. | Cut Guide | 2024-04-19 |
| Treace Medical Concepts, Inc. | TMC PSI Cut Guide System | 2024-03-19 |
| Treace Medical Concepts, Inc. | TMC PSI Cut Guide System | 2024-03-19 |
| Treace Medical Concepts, Inc. | Lapiplasty SpeedPlate | 2024-02-22 |
| Treace Medical Concepts, Inc. | Derotation Pin Guide | 2024-02-13 |
| Treace Medical Concepts, Inc. | Instrument Tray | 2024-01-30 |
| Treace Medical Concepts, Inc. | Drill | 2024-01-26 |
| Treace Medical Concepts, Inc. | K-Wire | 2024-01-03 |
| Treace Medical Concepts, Inc. | Half Pin | 2024-01-03 |
| Treace Medical Concepts, Inc. | Incision Guide | 2023-12-29 |
| Treace Medical Concepts, Inc. | Cut Guide | 2023-12-29 |
| Treace Medical Concepts, Inc. | Cut Guide | 2023-12-29 |
| Treace Medical Concepts, Inc. | Drill Tack | 2023-12-28 |
| Treace Medical Concepts, Inc. | Retraction Drill Guide | 2023-12-28 |
| Treace Medical Concepts, Inc. | Instrument Tray | 2023-12-21 |
| Treace Medical Concepts, Inc. | Instrument Tray | 2023-12-21 |
| Treace Medical Concepts, Inc. | Drill Bit | 2023-12-14 |
| Treace Medical Concepts, Inc. | Drill Bit | 2023-12-14 |
| Treace Medical Concepts, Inc. | Drill Bit | 2023-12-14 |
| Treace Medical Concepts, Inc. | Anatomic Model | 2023-11-27 |
| Treace Medical Concepts, Inc. | TMC PSI Cut Guide System | 2023-11-27 |
| Treace Medical Concepts, Inc. | TMC PSI Cut Guide System | 2023-11-27 |
| Treace Medical Concepts, Inc. | TMC PSI Cut Guide System | 2023-11-27 |
| Treace Medical Concepts, Inc. | TMC PSI Cut Guide System | 2023-11-27 |
| Treace Medical Concepts, Inc. | TMC PSI Cut Guide System | 2023-11-27 |
| Treace Medical Concepts, Inc. | TMC PSI Cut Guide System | 2023-11-27 |
| Treace Medical Concepts, Inc. | TMC PSI Cut Guide System | 2023-11-27 |
| Treace Medical Concepts, Inc. | TMC PSI Cut Guide System | 2023-11-27 |
| Treace Medical Concepts, Inc. | Lapiplasty SpeedPlate | 2023-11-22 |
| Treace Medical Concepts, Inc. | Drill | 2023-11-21 |
| Treace Medical Concepts, Inc. | Olive Wire | 2023-11-21 |
| Treace Medical Concepts, Inc. | Compressor / Distractor | 2023-11-21 |
| Treace Medical Concepts, Inc. | Cross Joint Pin Guide, Right | 2023-11-21 |
| Treace Medical Concepts, Inc. | Alignment Guide | 2023-11-21 |
| Treace Medical Concepts, Inc. | Pin Guide, Right | 2023-11-21 |
| Treace Medical Concepts, Inc. | Pin Guide, Left | 2023-11-21 |
| Treace Medical Concepts, Inc. | Pin Guide, Right | 2023-11-21 |
| Treace Medical Concepts, Inc. | Pin Guide, Left | 2023-11-21 |
| Treace Medical Concepts, Inc. | Pin Guide, Right | 2023-11-21 |
| Treace Medical Concepts, Inc. | Pin Guide, Left | 2023-11-21 |
| Treace Medical Concepts, Inc. | Pin Guide, Right | 2023-11-21 |
| Treace Medical Concepts, Inc. | Pin Guide, Left | 2023-11-21 |
| Treace Medical Concepts, Inc. | Pin Guide, Right | 2023-11-21 |
| Treace Medical Concepts, Inc. | Pin Guide, Left | 2023-11-21 |
| Treace Medical Concepts, Inc. | Pin Guide, Right | 2023-11-21 |
| Treace Medical Concepts, Inc. | Pin Guide, Left | 2023-11-21 |
| Treace Medical Concepts, Inc. | Pin Guide Handle | 2023-11-21 |
| Treace Medical Concepts, Inc. | Derotation Handle | 2023-11-21 |
| Treace Medical Concepts, Inc. | Cross Joint Pin Guide, Left | 2023-11-21 |
| Treace Medical Concepts, Inc. | Drill | 2023-11-20 |
| Treace Medical Concepts, Inc. | K-Wire | 2023-11-20 |
| Treace Medical Concepts, Inc. | Compressor / Distractor | 2023-11-20 |
Treace Medical Concepts, Inc. | Treace Medical Concepts (TMC) Plating System | 2022-02-16 |
Treace Medical Concepts, Inc. | Treace Medical Concepts (TMC) Screw Fixation System | 2021-10-21 |
Treace Medical Concepts, Inc. | Treace Medical Concepts (TMC) Plating System | 2020-05-08 |
Treace Medical Concepts, Inc. | Treace Medical Concepts (TMC) Plating System | 2019-10-30 |
Treace Medical Concepts, Inc. | Treace Medical Concepts (TMC) Snap-Off Screw System | 2019-06-13 |
TREACE MEDICAL CONCEPTS, INC. | Lapiplasty | 2019-06-10 |
TREACE MEDICAL CONCEPTS, INC. | Lapiplasty | 2019-06-10 |
TREACE MEDICAL CONCEPTS, INC. | TMC Ratchet Handle | 2019-06-10 |
Treace Medical Concepts, Inc. | Treace Medical Concepts (TMC) Plating System | 2019-01-25 |
Treace Medical Concepts, Inc. | PYTHON Plate Trial Instruments | 2018-03-19 |
TREACE MEDICAL CONCEPTS, INC. | Lapiplasty | 2018-03-13 |
Treace Medical Concepts, Inc. | Treace Medical Concepts (TMC) Compression Screw System | 2017-10-25 |
TREACE MEDICAL CONCEPTS, INC. | Control 360 | 2016-12-08 |
TREACE MEDICAL CONCEPTS, INC. | Lapidus Control | 2016-03-01 |
TREACE MEDICAL CONCEPTS, INC. | Control 360 | 2016-03-01 |
TREACE MEDICAL CONCEPTS, INC. | Treace Medical Concepts (TMC) Plating System | 2016-01-07 |
TREACE MEDICAL CONCEPTS, INC. | Lapidus Control | 2015-10-06 |
TREACE MEDICAL CONCEPTS, INC. | Control 360 | 2015-10-06 |
TREACE MEDICAL CONCEPTS, INC. | Lapidus Control | 2015-10-06 |
TREACE MEDICAL CONCEPTS, INC. | Control 360 | 2015-10-06 |
TREACE MEDICAL CONCEPTS, INC. | Triplane Positioner | 2015-10-06 |
TREACE MEDICAL CONCEPTS, INC. | Lapidus Control Instrument Organizing Tray | 2015-10-06 |
TREACE MEDICAL CONCEPTS, INC. | Control Cut Joint Seeker | 2015-10-06 |
TREACE MEDICAL CONCEPTS, INC. | Control Cut Guide Size 5 | 2015-10-06 |
TREACE MEDICAL CONCEPTS, INC. | Control Cut Guide Size 4 | 2015-10-06 |
Treace Medical Concepts, INc. | Treace Medical Concepts(TMC) Plating System | 2015-03-19 |
| NCAGE Code | 7RVW6 | TREACE MEDICAL CONCEPTS, INC. |
| CAGE Code | 7RVW6 | TREACE MEDICAL CONCEPTS, INC. |
| S.A.M. Registration | 7RVW6 [54808082] | TREACE MEDICAL CONCEPTS, INC. |
| SEC | 0001630627 | TREACE MEDICAL CONCEPTS, INC. of DELAWARE |