Anteralign LS coverplate— 510(k) K260810
Substantially EquivalentTyber Medical, LLC
FDA 510(k) clearance K260810 for Anteralign LS coverplate, Substantially Equivalent on 2026-06-10. Applicant: Tyber Medical, LLC. Device class: 2.
Summary
Tyber Medical's Anteralign LS coverplate is filed under OVD, lumbar intervertebral fusion devices with integrated fixation. The record doesn't expand "LS" or give sizes.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Tyber filed from Bethlehem, Pennsylvania. The decision came 90 calendar days after receipt (March 12 to June 10, 2026).
Clearance details
- Applicant
- Tyber Medical, LLC
- Product code
- Product code OVD
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethlehem, PA, US
Recent devices under product code OVD
view allMore clearances from Tyber Medical, LLC
view allAdverse events under product code OVD
product code OVD- Death
- 5
- Injury
- 495
- Total
- 500
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.