510(k) K263269
K263269 is an FDA 510(k) premarket notification submitted by Tdm Co., Ltd. for the device "Park's Pectus System". The FDA issued a decision of Substantially Equivalent on Oct 15, 2026. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Tdm Co., Ltd. has 13 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 15, 2026
- Date Received
- Sep 18, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)