510(k) K252081
K252081 is an FDA 510(k) premarket notification submitted by Lincotek Medical for the device "SportLinc Syndesmosis Device". The FDA issued a decision of Substantially Equivalent on March 27, 2026. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Lincotek Medical has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2026
- Date Received
- July 2, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Washer, Bolt Nut
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type