510(k) K251569
K251569 is an FDA 510(k) premarket notification submitted by Osstem Implant Co., Ltd. for the device "Bone Screw". The FDA issued a decision of Substantially Equivalent on August 13, 2025. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880. Osstem Implant Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 2025
- Date Received
- May 22, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Intraosseous
- Device Class
- Class II
- Regulation Number
- 872.4880
- Review Panel
- DE
- Submission Type