CEZANNE II INTERBODY FUSION SYSTEM— 510(k) K131981

Clearance details

Applicant

Accel Spine

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2013-06-28

Decision date

2013-10-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Dallas, TX, US

• 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

• K140219 — PICASSO II MIS SPINAL SYSTEM2014-04-14
• 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
• K121568 — DALI SPINAL FIXATION SYSTEM2012-09-21

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 →

• Z-2501-2020 — CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.Class II·Completed·CTL Medical Corporation·20190821
• Z-2502-2020 — CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.Class II·Completed·CTL Medical Corporation·20190821
• Z-2503-2020 — CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.Class II·Completed·CTL Medical Corporation·20190821
• Z-2504-2020 — CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.Class II·Completed·CTL Medical Corporation·20190821

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131981.