Exceed® Biplanar Expandable Interbody System— 510(k) K261159

Name: FDA 510(k) clearance K261159
Creator: U.S. Food and Drug Administration
Published: 2026-05-29

Substantially Equivalent

Spine Wave, Inc.

FDA 510(k) clearance K261159 for Exceed® Biplanar Expandable Interbody System, Substantially Equivalent on 2026-05-29. Applicant: Spine Wave, Inc.. Device class: 2.

Clearance details

Applicant: Spine Wave, Inc.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2026-04-08
Decision date: 2026-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, US

Download summary PDF View on FDA.gov ↗

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K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
K253420 — Admiral ACP System +18 more2026-07-01

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K243514 — Salvo® Robotic Navigation Instruments2025-04-03
K240685 — Salvo® Spine System2024-05-06

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.