SPINAL USA VBR SYSTEM— 510(k) K081196

Name: FDA 510(k) clearance K081196
Creator: U.S. Food and Drug Administration
Published: 2008-10-16

Substantially Equivalent

Spinal USA

FDA 510(k) clearance K081196 for SPINAL USA VBR SYSTEM, Substantially Equivalent on 2008-10-16. Applicant: Spinal USA. Device class: 2.

Clearance details

Applicant: Spinal USA
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2008-04-28
Decision date: 2008-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flowood, MS, 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 Spinal USA

view all

K132029 — VAULT-C INTERVERTEBRAL BODY FUSION DEVICE2013-11-25
K130863 — FACET SCREW SYSTEM2013-08-09
K131343 — REFORM PEDICLE SCREW SYSTEM2013-07-24
K130279 — REFORM PEDICLE SCREW SYSTEM2013-06-20
K130445 — VAULT ALIF SYSTEM2013-04-25

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.