Exalta Proximal Tibia Plating System— 510(k) K261207
Substantially EquivalentTyber Medical, LLC
FDA 510(k) clearance K261207 for Exalta Proximal Tibia Plating System, Substantially Equivalent on 2026-06-12. Applicant: Tyber Medical, LLC. Device class: 2.
Summary
Tyber Medical's Exalta Proximal Tibia Plating System is filed under HRS, bone fixation plates. The record doesn't list the system's 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).
Tyber filed from Bethlehem, Pennsylvania. The decision came 60 calendar days after receipt (April 13 to June 12, 2026).
Clearance details
- Applicant
- Tyber Medical, LLC
- Product code
- Product code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethlehem, PA, US
Recent devices under product code HRS
view allMore clearances from Tyber Medical, LLC
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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.