FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
TDM Plate and Screw Systems
K Number: K190391
·
Decision Nov 15, 2019
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
11
Review Days
269
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Basic Information
- Device Name
- TDM Plate and Screw Systems
- K Number
- K190391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tdm Co., Ltd.
- Date Received
- February 19, 2019
- Decision Date
- November 15, 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
Other 510(k) clearances with the same product code (HRS), ordered by most recent decision date.
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 Tdm Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K241128 | TDM Plate and Screw System | Dec 5, 2024 | Substantially Equivalent |
| K230071 | Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System | Aug 22, 2024 | Substantially Equivalent |
| K240423 | TDM Anterior Cervical Plate System | Apr 8, 2024 | Substantially Equivalent |
| K232115 | TDM Large Bone Plate and Screw System | Apr 5, 2024 | Substantially Equivalent |
| K231860 | TDM Screw System | Jan 18, 2024 | Substantially Equivalent |
| K221844 | TDM Lumbar Interbody Fusion Cage System | Aug 17, 2022 | Substantially Equivalent |
| K220285 | PINE Pedicle Screw System | May 19, 2022 | Substantially Equivalent |
| K191057 | Park's Pectus System | Mar 19, 2020 | Substantially Equivalent |
| K190830 | TDM Screw Systems | Sep 13, 2019 | Substantially Equivalent |
| K171808 | TDM Plate and Screw System | Mar 15, 2018 | Substantially Equivalent |