Interwedge® Standalone Lateral— 510(k) K261809

Name: FDA 510(k) clearance K261809
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Substantially Equivalent

Foundation Surgical Group

FDA 510(k) clearance K261809 for Interwedge® Standalone Lateral, Substantially Equivalent on 2026-07-31. Applicant: Foundation Surgical Group. Device class: 2.

Summary

Foundation Surgical Group's Interwedge Standalone Lateral is filed under OVD, lumbar intervertebral fusion devices with integrated fixation. The record doesn't give sizes, materials, or components.

Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel, and it came in as a Special 510(k).

Foundation Surgical Group filed from Scottsdale, Arizona. Review took 60 calendar days (June 1 to July 31, 2026).

Clearance details

Applicant: Foundation Surgical Group
Product code: Product code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2026-06-01
Decision date: 2026-07-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVD

view all

K262025 — Innovasis AxTiHA® Stand-Alone ALIF System +2 more2026-09-11
K261408 — SABER-XA System2026-08-03
K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System2026-07-15
K260810 — Anteralign LS coverplate2026-06-10
K254202 — MectaLIF 3D Metal Anterior2026-05-05

More clearances from Foundation Surgical Group

view all

K261810 — Vertiwedge® Intraosseous System2026-07-31

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.