Anteralign LS coverplate— 510(k) K260810

Name: FDA 510(k) clearance K260810
Creator: U.S. Food and Drug Administration
Published: 2026-06-10

Substantially Equivalent

Tyber Medical, LLC

FDA 510(k) clearance K260810 for Anteralign LS coverplate, Substantially Equivalent on 2026-06-10. Applicant: Tyber Medical, LLC. Device class: 2.

Clearance details

Applicant: Tyber Medical, LLC
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2026-03-12
Decision date: 2026-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVD

view all

K261408 — SABER-XA System2026-08-03
K261809 — Interwedge® Standalone Lateral2026-07-31
K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System2026-07-15
K254202 — MectaLIF 3D Metal Anterior2026-05-05
K253401 — SCRIPT Implant System2026-04-29

More clearances from Tyber Medical, LLC

view all

K261207 — Exalta Proximal Tibia Plating System2026-06-12
K261060 — Navigated LLIF Impactable Tracker2026-05-29
K253042 — Tyber Medical Trauma Screw2026-04-03
K252901 — Tyber Medical Trauma Screw2025-12-31
K252742 — Navigated Instruments2025-10-28

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.