SportLinc Syndesmosis Device— 510(k) K252081
Substantially EquivalentLincotek Medical
FDA 510(k) clearance K252081 for SportLinc Syndesmosis Device, Substantially Equivalent on 2026-03-27. Applicant: Lincotek Medical. Device class: 2.
Summary
Lincotek Medical's SportLinc Syndesmosis Device is filed under HTN, bolt nut washers. The record doesn't list sizes or components.
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Lincotek Medical filed from Bartlett, Tennessee. Review took 268 calendar days (July 2, 2025 to March 27, 2026).
Clearance details
- Applicant
- Lincotek Medical
- Product code
- Product code HTN
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bartlett, TN, US
Recent devices under product code HTN
view allMore clearances from Lincotek Medical
view allAdverse events under product code HTN
product code HTN- Injury
- 310
- Malfunction
- 639
- Total
- 949
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.