Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices— 510(k) K223065

Name: FDA 510(k) clearance K223065
Creator: U.S. Food and Drug Administration
Published: 2022-10-26

Substantially Equivalent

Adcura, Inc.

FDA 510(k) clearance K223065 for Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices, Substantially Equivalent on 2022-10-26. Applicant: Adcura, Inc.. Device class: 2.

Clearance details

Applicant: Adcura, Inc.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2022-09-30
Decision date: 2022-10-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAX

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K261049 — SCALA® TL2026-08-20
K261430 — TruLift Expandable System2026-07-28
K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
K253420 — Admiral ACP System +18 more2026-07-01

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.