Bluefin Interbody System— 510(k) K143479

Name: FDA 510(k) clearance K143479
Creator: U.S. Food and Drug Administration
Published: 2015-09-25

Substantially Equivalent

Tides Medical

FDA 510(k) clearance K143479 for Bluefin Interbody System, Substantially Equivalent on 2015-09-25. Applicant: Tides Medical. Device class: 2.

Clearance details

Applicant: Tides Medical
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2014-12-08
Decision date: 2015-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette, LA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAX

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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

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.