510(k) K231860
- Device
- TDM Screw System
- Applicant
- Tdm Co., Ltd.
- 510(k) number
- K231860
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-01-18
- Date received
- 2023-06-23
- Regulation
- 888.3040
- Classification name
- Screw, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Jung Wook Choi
- Address
- 69, Cheomdan Venture So-Ro 37 Beon-Gil Buk-Gu KR 61003 61003
FDA Registration Numbers
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Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800043918384 | N/A | TDM Co., Ltd. | 2024-07-23 |
| 08800043935718 | N/A | TDM Co., Ltd. | 2024-07-23 |
| 08800043935572 | N/A | TDM Co., Ltd. | 2024-07-23 |
| 08800043935565 | N/A | TDM Co., Ltd. | 2024-07-23 |
| 08800043918728 | N/A | TDM Co., Ltd. | 2024-07-23 |
| 08800043918711 | N/A | TDM Co., Ltd. | 2024-07-23 |
| 08800043918704 | N/A | TDM Co., Ltd. | 2024-07-23 |
| 08800043918681 | N/A | TDM Co., Ltd. | 2024-07-23 |
| 08800043918629 | N/A | TDM Co., Ltd. | 2024-07-23 |
| 08800043918612 | N/A | TDM Co., Ltd. | 2024-07-23 |
| 08800043918582 | N/A | TDM Co., Ltd. | 2024-07-23 |
| 08800043918568 | N/A | TDM Co., Ltd. | 2024-07-23 |
| 08800043918544 | N/A | TDM Co., Ltd. | 2024-07-23 |
| 08800043918636 | N/A | TDM Co., Ltd. | 2024-07-23 |
| 08800043918483 | N/A | TDM Co., Ltd. | 2024-07-22 |
| 08800043918476 | N/A | TDM Co., Ltd. | 2024-07-22 |
| 08800043918469 | N/A | TDM Co., Ltd. | 2024-07-22 |
| 08800043918452 | N/A | TDM Co., Ltd. | 2024-07-22 |
| 08800043918445 | N/A | TDM Co., Ltd. | 2024-07-22 |
| 08800043918438 | N/A | TDM Co., Ltd. | 2024-07-22 |
| 08800043918421 | N/A | TDM Co., Ltd. | 2024-07-22 |
| 08800043918414 | N/A | TDM Co., Ltd. | 2024-07-22 |
| 08800043918407 | N/A | TDM Co., Ltd. | 2024-07-22 |
| 08800043918391 | N/A | TDM Co., Ltd. | 2024-07-22 |
| 08800043918377 | N/A | TDM Co., Ltd. | 2024-07-22 |
| 08800043918360 | N/A | TDM Co., Ltd. | 2024-07-22 |
| 08800043918353 | N/A | TDM Co., Ltd. | 2024-07-22 |
| 08800043918490 | N/A | TDM Co., Ltd. | 2024-07-22 |
| 08800043935589 | N/A | TDM Co., Ltd. | 2024-07-22 |
| 08800043935725 | N/A | TDM Co., Ltd. | 2024-07-22 |
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