510(k) K241357
K241357 is an FDA 510(k) premarket notification submitted by Biodynamik, Inc. for the device "XT3 System". The FDA issued a decision of Substantially Equivalent on January 22, 2025. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Biodynamik, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2025
- Date Received
- May 14, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Threaded
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type