510(k) clearance
TDM Large Bone Plate and Screw System
- 510(k) number
- K261611
- Applicant
- Tdm Co., Ltd.
- Decision date
- Oct 2, 2026
- Date received
- May 15, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- HRS
- Device type
- Plate, Fixation, Bone
- Device class
- Class II
- Regulation
- 21 CFR 888.3030
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Gwangju, KR