TALOS INTERVERTEBRAL BODY FUSION DEVICE— 510(k) K090707

Name: FDA 510(k) clearance K090707
Creator: U.S. Food and Drug Administration
Published: 2009-07-15

Substantially Equivalent

Meditech Advisors, LLC

FDA 510(k) clearance K090707 for TALOS INTERVERTEBRAL BODY FUSION DEVICE, Substantially Equivalent on 2009-07-15. Applicant: Meditech Advisors, LLC. Device class: 2.

Clearance details

Applicant: Meditech Advisors, LLC
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2009-03-17
Decision date: 2009-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAX

view all

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 Meditech Advisors, LLC

view all

K122850 — TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES2013-03-28

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.