PLATEAU SPACER SYSTEM— 510(k) K080411

Name: FDA 510(k) clearance K080411
Creator: U.S. Food and Drug Administration
Published: 2008-05-15

Substantially Equivalent

Life Spine

FDA 510(k) clearance K080411 for PLATEAU SPACER SYSTEM, Substantially Equivalent on 2008-05-15. Applicant: Life Spine. Device class: 2.

Clearance details

Applicant: Life Spine
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2008-02-15
Decision date: 2008-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoffman Estates, IL, 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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K141905 — PRO-LINK WEDGE SYSTEM2014-09-26
K133717 — LONGBOW SPACER SYSTEM2014-09-19

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.