DeviceClearance

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

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.

Summary

Spine Wave's Exceed Biplanar Expandable Interbody System is filed under MAX, lumbar intervertebral fusion devices with bone graft.

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

Spine Wave filed from Shelton, Connecticut. The decision came 51 calendar days after receipt (April 8 to May 29, 2026).

Clearance details

Applicant
Spine Wave, Inc.
Product code
Product code MAX
Device class
Class 2
Regulation
21 CFR 888.3080
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shelton, CT, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MAX

product code MAX
Death
13
Injury
1,305
Malfunction
2,885
Total
4,203

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.