Toro-L Interbody Fusion System— 510(k) K213355

Name: FDA 510(k) clearance K213355
Creator: U.S. Food and Drug Administration
Published: 2022-03-25

Substantially Equivalent

Integrity Implants, Inc.

FDA 510(k) clearance K213355 for Toro-L Interbody Fusion System, Substantially Equivalent on 2022-03-25. Applicant: Integrity Implants, Inc.. Device class: 2.

Clearance details

Applicant: Integrity Implants, Inc.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2021-10-12
Decision date: 2022-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, 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

More clearances from Integrity Implants, Inc.

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K231098 — LineSider® Spinal System2023-08-07
K220453 — FlareHawk Interbody Fusion System2022-03-24
K212088 — Integrity Implants Navigated Instruments2021-12-23
K203038 — Toro-L Interbody Fusion System2021-03-26
K203367 — LineSider Spinal System2020-12-03

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.