DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS— 510(k) K081917

Name: FDA 510(k) clearance K081917
Creator: U.S. Food and Drug Administration
Published: 2009-05-22

Substantially Equivalent

Depuy Spine, Inc.

FDA 510(k) clearance K081917 for DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS, Substantially Equivalent on 2009-05-22. Applicant: Depuy Spine, Inc.. Device class: 2.

Clearance details

Applicant: Depuy Spine, Inc.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2008-07-03
Decision date: 2009-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, 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 Depuy Spine, Inc.

view all

K201831 — CONFIDENCE Spinal Cement System2020-08-31
K142185 — EXPEDIUM VERSE SPINE SYSTEM2014-11-19
K111136 — EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM2012-06-14
K121020 — VIPER SYSTEM2012-05-03
K110353 — MOUNTAINEER OCT SPINAL SYSTEM2011-04-07

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.