DALI SPINAL FIXATION SYSTEM— 510(k) K121568

Clearance details

Applicant

Accel Spine

Product code

Code NKB

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2012-05-29

Decision date

2012-09-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Dallas, TX, US

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• K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD2026-07-01

• K140219 — PICASSO II MIS SPINAL SYSTEM2014-04-14
• K131981 — CEZANNE II INTERBODY FUSION SYSTEM2013-10-09
• K132366 — SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS2013-09-03
• K132365 — SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION2013-08-20
• K121567 — ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM2012-09-26

Death

27

Injury

5,033

Malfunction

4,140

Total

9,200

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 →