FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Treace Medical Concepts (TMC) Plating System
K Number: K183321
·
Decision Jan 25, 2019
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
15
Review Days
56
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Basic Information
- Device Name
- Treace Medical Concepts (TMC) Plating System
- K Number
- K183321
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Treace Medical Concepts, Inc.
- Date Received
- November 30, 2018
- Decision Date
- January 25, 2019
- Product Code
- HRS
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L
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Other Clearances by Treace Medical Concepts, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260361 | Treace Medical Concepts (TMC) Screw Fixation System | Mar 6, 2026 | Substantially Equivalent |
| K242671 | Treace Medical Concepts (TMC) Screw Fixation System | Oct 4, 2024 | Substantially Equivalent |
| K240173 | Treace Medical Systems (TMC) Plating System | Feb 22, 2024 | Substantially Equivalent |
| K221181 | Treace Medical Concepts (TMC) Plating System | Jan 5, 2023 | Substantially Equivalent |
| K222564 | Treace Medical Concepts (TMC) Hammertoe Fixation System | Nov 15, 2022 | Substantially Equivalent |
| K220136 | Treace Medical Concepts (TMC) Plating System | Feb 16, 2022 | Substantially Equivalent |
| K213036 | Treace Medical Concepts (TMC) Screw Fixation System | Oct 21, 2021 | Substantially Equivalent |
| K200961 | Treace Medical Concepts (TMC) Plating System | May 8, 2020 | Substantially Equivalent |
| K192504 | Treace Medical Concepts (TMC) Plating System | Oct 30, 2019 | Substantially Equivalent |
| K183363 | Treace Medical Concepts (TMC) Snap-Off Screw System | Jun 13, 2019 | Substantially Equivalent |